MAUDE Adverse Event Report: CORDIS CORPORATION 6F 10CM HW RADIAL; INTRODUCER, CATHETER

Catalog Number 506610H

Device Problem Partial Blockage (1065)

Patient Problem Hematoma (1884)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review of lot 17831273 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, the dilator is too soft and the mini guidewire cannot access the dilator on the 6f rain sheath transradial.The insertion difficulty was caused by a blockage of possibly injectable material.The.021¿ mini guidewire caused a 5cm hematoma.The hematoma was treated with compression, without sequela.The doctor states the mini guidewire is too floppy.The device was stored in the cath lab in the rain sheath box for a maximum of three weeks.The device was inspected and prepped per the instructions for use (ifu).The dilator was hard to wire as there was a very small lumen in the dilator.The device did not kink or bend at any time prior to the insertion difficulty.The product nor any of the other devices had been resterilized.The malfunction was noted during prep.The intended procedure was a percutaneous coronary intervention (pci).There was no difficulty tracking through the vasculature.No unusual force was used at any time during the procedure.The procedure was completed with a non-cordis sheath.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the dilator is too soft and the mini guidewire cannot access the dilator on the 6f rain transradial sheath introducer.The insertion difficulty was caused by a blockage of possibly injectable material.The.021¿ mini guidewire caused a 5cm hematoma.The hematoma was treated with compression, without sequelae.The doctor states the mini guidewire is too floppy.The device was stored in the cath lab in the rain sheath box for a maximum of three weeks.The device was inspected and prepped per the instructions for use (ifu).The dilator was hard to wire as there was a very small lumen in the dilator.The device did not kink or bend at any time prior to the insertion difficulty.The product nor any of the other devices had been resterilized.The malfunction was noted during prep.The intended procedure was a percutaneous coronary intervention (pci).There was no difficulty tracking through the vasculature.No unusual force was used at any time during the procedure.The procedure was completed with a non-cordis sheath.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.One non-sterile 6f 10cm hw radial was received for analysis inside a plastic bag.The mini guidewire was not returned.Per visual analysis, the vessel dilator was loaded into the sheath.No anomalies were observed.A lab sample syringe filled with water was attached to the hub of the received vessel dilator unit and successfully flushed.Neither resistance nor obstruction was observed during the flushing procedure.Then, a 0.021¿ emerald guidewire lab sample was introduced in the unit via the hub.Functional test was successfully performed, and neither resistance nor obstruction was experienced during the procedure.Also, 9 sterile 6f 10cm hw radial units in their original package were received along with the complaint product.2 out of the 9 sterile units were analyzed.The units were returned in their original packages and sealed.The 2 units were opened and, per visual analysis, both packages contained a 6f vessel dilator, a 6f catheter sheath introducer (csi), a needle and a 0.021¿ mini guidewire.No damages or anomalies were observed on the mentioned devices.A lab sample syringe filled with water was attached to the hub of the received vessel dilator unit and in csi for the sterile units received; vessel dilators and csis for both sterile units successfully flushed.Neither resistance nor obstruction was observed during flushing procedure.Then, the 0.021¿ mini guidewires received in both packages were introduce in their corresponding vessel dilators.Functional test was successfully performed in both sterile units, neither resistance nor obstruction was experienced during both the procedure.A product history record (phr) review of lot 1783127 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿mini guidewire impeded in patient¿ was not confirmed as this component was not returned for analysis.Additionally, there were no anomalies noted with the mini guidewires of the sterile device.The reported ¿vessel dilator obstructed in patient¿ was not confirmed since the device passed functional analysis and no anomalies were noted with the sterile devices.The exact cause of the issue experienced could not be conclusively determined during analysis.Access site hematomas are a common procedural complication and is listed in the rain catheter sheath introducer¿s (csi) instructions for use (ifu) as such.The hematoma could not be confirmed as well.Based on the information available and the product analysis, access site factors and handling of the mini guidewire and vessel dilator likely contributed to this issue experienced with threading the vessel dilator over the mini guidewire placed in the patient and led to the subsequent hematoma.As cautioned in the rain sheath ifu, which is not intended as a mitigation, ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ as stated in the recommended procedure, ¿introduce the needle into the vessel using an aseptic technique.Holding the needle in place, insert the flexible end of the mini-guidewire through the needle and into the vessel.Gently advance the guidewire to the desired depth.Do not withdraw the guidewire back though the metal cannula of the needle after it has been inserted as it may damage the guidewire.Holding the guidewire in place, withdraw the needle and apply pressure to the puncture site until the csi is inserted into the vasculature.Thread the csi with vessel dilator over the guidewire, grasping the sheath close to the skin to prevent buckling.Advance the assembly through the tissue and into the vessel.Caution: to prevent damage to the csi tip or kinking of the csi body, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel.¿ neither the phr review nor the product analyses suggest that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions have been taken at this time.However, a risk assessment has been initiated to further investigate these type of complaints.

Manufacturer Narrative

Section b5 description of event: as reported, the dilator is too soft and the mini guidewire cannot access the dilator on the 6f rain sheath transradial.The insertion difficulty was caused by a blockage of possibly injectable material.The.021¿ mini guidewire caused a 5cm hematoma.The hematoma was treated with compression, without sequela.The doctor states the mini guidewire is too floppy.The dilator had a small hole with residual material covering the tip/entrance.When flushing the dilator, water came out from the tip sideways at a ninety-degree angle and the wire could not enter the tip from the front/hub.The hematoma was caused by the wire because the wire took a side branch over the main vessel, which could not be felt due to the very floppy nature of the tip.The device was stored in the cath lab in the rain sheath box for a maximum of three weeks.The device was inspected and prepped per the instructions for use (ifu).The dilator was hard to wire as there was a very small lumen in the dilator.The device did not kink or bend at any time prior to the insertion difficulty.The product nor any of the other devices had been resterilized.The malfunction was noted during prep.The intended procedure was a percutaneous coronary intervention (pci).There was no difficulty tracking through the vasculature.No unusual force was used at any time during the procedure.The procedure was completed with a non-cordis sheath.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.As reported, the dilator is too soft and the mini guidewire cannot access the dilator on the 6f rain sheath transradial.The insertion difficulty was caused by a blockage of possibly injectable material.The.021¿ mini guidewire caused a 5cm hematoma.The hematoma was treated with compression, without sequela.The doctor states the mini guidewire is too floppy.The dilator had a small hole with residual material covering the tip/entrance.When flushing the dilator, water came out from the tip sideways at a ninety-degree angle and the wire could not enter the tip from the front/hub.The hematoma was caused by the wire because the wire took a side branch over the main vessel, which could not be felt due to the very floppy nature of the tip.The device was stored in the cath lab in the rain sheath box for a maximum of three weeks.The device was inspected and prepped per the instructions for use (ifu).The dilator was hard to wire as there was a very small lumen in the dilator.The device did not kink or bend at any time prior to the insertion difficulty.The product nor any of the other devices had been resterilized.The malfunction was noted during prep.The intended procedure was a percutaneous coronary intervention (pci).There was no difficulty tracking through the vasculature.No unusual force was used at any time during the procedure.The procedure was completed with a non-cordis sheath.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.One non-sterile 6f 10cm hw radial was received for analysis inside a plastic bag.The mini guidewire was not returned.Per visual analysis, the vessel dilator was loaded into the sheath.No anomalies were observed.A lab sample syringe filled with water was attached to the hub of the received vessel dilator unit and successfully flushed.Neither resistance nor obstruction was observed during the flushing procedure.Then, a 0.021¿ emerald guidewire lab sample was introduced in the unit via the hub.Functional test was successfully performed, and neither resistance nor obstruction was experienced during the procedure.Also, 9 sterile 6f 10cm hw radial units in their original package were received along with the complaint product.2 out of the 9 sterile units were analyzed.The units were returned in their original packages and sealed.The 2 units were opened and, per visual analysis, both packages contained a 6f vessel dilator, a 6f catheter sheath introducer (csi), a needle and a 0.021¿ mini guidewire.No damages or anomalies were observed on the mentioned devices.A lab sample syringe filled with water was attached to the hub of the received vessel dilator unit and in csi for the sterile units received; vessel dilators and csis for both sterile units successfully flushed.Neither resistance nor obstruction was observed during flushing procedure.Then, the 0.021¿ mini guidewires received in both packages were introduce in their corresponding vessel dilators.Functional test was successfully performed in both sterile units, neither resistance nor obstruction was experienced during both the procedure.A product history record (phr) review of lot 1783127 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿mini guidewire impeded in patient¿ was not confirmed as this component was not returned for analysis.Additionally, there were no anomalies noted with the mini guidewires of the sterile device.The reported ¿vessel dilator obstructed in patient¿ was not confirmed since the device passed functional analysis and no anomalies were noted with the sterile devices.The exact cause of the issue experienced could not be conclusively determined during analysis of the returned products.Access site hematomas are a common procedural complication and is listed in the rain catheter sheath introducer¿s (csi) instructions for use (ifu) as such.The hematoma could not be confirmed as well.Based on the information available and the product analysis, handling factors of the components may have contributed to this issue experienced.As cautioned in the rain sheath ifu, which is not intended as a mitigation, ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ as stated in the recommended procedure, ¿introduce the needle into the vessel using an aseptic technique.Holding the needle in place, insert the flexible end of the mini-guidewire through the needle and into the vessel.Gently advance the guidewire to the desired depth.Do not withdraw the guidewire back though the metal cannula of the needle after it has been inserted as it may damage the guidewire.Holding the guidewire in place, withdraw the needle and apply pressure to the puncture site until the csi is inserted into the vasculature.Thread the csi with vessel dilator over the guidewire, grasping the sheath close to the skin to prevent buckling.Advance the assembly through the tissue and into the vessel.Caution: to prevent damage to the csi tip or kinking of the csi body, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel.¿ neither the phr review nor the product analyses suggest that the reported failures are related to the manufacturing process of the unit; therefore, no corrective/preventative actions have been taken at this time.However, a risk assessment has been initiated to further investigate these type of complaints.

Event Description

As reported, the dilator is too soft and the mini guidewire cannot access the dilator on the 6f rain sheath transradial.The insertion difficulty was caused by a blockage of possibly injectable material.The.021¿ mini guidewire caused a 5cm hematoma.The hematoma was treated with compression, without sequela.The doctor states the mini guidewire is too floppy.The dilator had a small hole with residual material covering the tip/entrance.When flushing the dilator, water came out from the tip sideways at a ninety-degree angle and the wire could not enter the tip from the front/hub.The hematoma was caused by the wire because the wire took a side branch over the main vessel, which could not be felt due to the very floppy nature of the tip.The device was stored in the cath lab in the rain sheath box for a maximum of three weeks.The device was inspected and prepped per the instructions for use (ifu).The dilator was hard to wire as there was a very small lumen in the dilator.The device did not kink or bend at any time prior to the insertion difficulty.The product nor any of the other devices had been resterilized.The malfunction was noted during prep.The intended procedure was a percutaneous coronary intervention (pci).There was no difficulty tracking through the vasculature.No unusual force was used at any time during the procedure.The procedure was completed with a non-cordis sheath.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.

• Brand Name: 6F 10CM HW RADIAL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8789270
• MDR Text Key: 150991773
• Report Number: 9616099-2019-03075
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10705032079037
• UDI-Public: 10705032079037
• Combination Product (y/n): N
• PMA/PMN Number: K181592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 506610H
• Device Lot Number: 17831273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO SLENDER SHEATH; TERUMO SLENDER SHEATH