MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6 ST JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532621

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17731366) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.Code (b)(4) was used as there is no code for prolonged hospitalization.

Event Description

As reported, the 6f avanti+ catheter sheath introducer was introducted into patient¿s groin.Then, the jr 4 super torque diagnostic guide catheter was inserted through the sheath and the tip was placed in the aorta.The physician stated that he was having difficulty manipulating the jr4.Later, the physician tried to pull the jr4 back but it became hung up.The physician continued to pull and by doing so the jr4 catheter broke.Half of the jr4 catheter was in the physicians hand and the distal end was inside the sheath and patient.The patient had to be taken to the operating room to have the distal end of the jr4 catheter and sheath removed.There was no reported patient injury.The patient is recovering.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.The catheter was not re-shaped by the user.There were no anomalies noted during or after the device was prepped.The catheter was not kinked or damaged in any way prior to insertion into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was torqued in order to try to engage the coronary artery.There was no issue with the 6f avanti+ catheter sheath introducer (csi).The sheath was noted to be ¿accordioned¿ after removal.The catheter was kinked.The device will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g4, h2, h3 and h6 have been updated accordingly.During an unknown procedure a jr 4 super torque catheter was inserted through the sheath introducer in the patient¿s groin and, the tip of the catheter was placed in the aorta.The physician stated that he was having difficulty manipulating the jr4.Later, the physician tried to pull the jr4 back but it became hung up.The physician continued to pull and by doing so the jr4 catheter broke.Half of the jr4 catheter was in the physician¿s hand and the distal end was inside the sheath and patient.The patient had to be taken to the operating room to have the distal end of the jr4 catheter and sheath removed.The patient is recovering.Vessel details are unknown.The case was aborted related to device issues.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.The catheter was not re-shaped by the user.There were no anomalies noted during or after the device was prepped.The catheter was not kinked or damaged in any way prior to insertion into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was torqued to try to engage the coronary artery.The catheter was noted to be kinked after removal.The device was returned for analysis.One non-sterile cath f6 st jr 4 100cm was received inside a plastic bag.The body was separated at 31 cm from hub.Per dimensional analysis tthe od and id of the returned unit were measured near the separation and no anomalies were found.Per scanning electron microscope (sem) analysis showed that the catheter¿s separated areas presented with material deformation and evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.The braid wire presented with plastic deformation that resulted in a diameter reduction of wire that is associated with ductile separations caused by material tensile overload.No other issues were noted during sem analysis.A review of the manufacturing documentation associated with lot 17731366 was performed and no issues were noted that may be related to the reported complaint.No other issues were noted that were considered potentially related to the reported complaint.The product history record (phr) review does not suggest that the failure experienced by the customer could be related to the manufacturing process.The event "brite tip/distal tip - catheters - separated - in-patient" reported by the customer was confirmed due to the condition of the returned unit.Sem analysis showed that the catheter¿s separated areas presented material deformation and evidence of elongations.The cause of the separated condition noted could not be conclusively determined during the analysis.Based on the limited information available for review, vessel characteristics (while unknown) as well as procedural factors such as excessive torqueing, may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.Torqueing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer)¿.Neither the phr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

During an unknown procedure a jr 4 super torque catheter was inserted through a 6f avanti+ catheter sheath introducer in the patient¿s groin and the tip of the catheter was placed in the aorta.The physician stated that he was having difficulty manipulating the jr4.Later, the physician tried to pull the jr4 back, but it became hung up.The physician continued to pull and by doing so the jr4 catheter broke.Half of the jr4 catheter was in the physician¿s hand and the distal end was inside the sheath and patient.The patient had to be taken to the operating room to have the distal end of the jr4 catheter and sheath removed.The patient is recovering.Vessel details are unknown.The case was aborted related to device issues.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.The catheter was not re-shaped by the user.There were no anomalies noted during or after the device was prepped.The catheter was not kinked or damaged in any way prior to insertion into the patient.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was torqued to try to engage the coronary artery.The catheter was noted to be kinked after removal.Two products were returned for analysis.One non-sterile catheter sheath introducer (csi) avanti+ cardiology ms.038 was received inside a plastic bag.Per visual analysis, the sheath introducer was received accordioned.No other discrepancies were found.A review of the manufacturing documentation associated with lot 17746173 was performed and no issues were noted that may be related to the reported complaint.No other issues were noted that were considered potentially related to the reported complaint.The product history record (phr) review does not suggest that the failure experienced by the customer could be related to the manufacturing process.One non-sterile cath f6 st jr 4 100cm was received inside a plastic bag.The body was separated at 31 cm from hub.Per dimensional analysis the od and id of the received unit were measured near the separation and no anomalies were found.Per sem analysis the catheter¿s separated areas presented with material deformation and evidence of elongations.The elongations noted suggest that the device was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.The braid wire presented with plastic deformation that resulted in a diameter reduction of wire that is associated with ductile separations caused by material tensile overload.No other issues were noted during sem analysis.A review of the manufacturing documentation associated with lot 17731366 was performed and no issues were noted that may be related to the reported complaint.No other issues were noted that were considered potentially related to the reported complaint.The product history record (phr) review does not suggest that the failure experienced by the customer could be related to the manufacturing process.The event "catheter sheath introducer (csi) - accordioned" reported by the customer was confirmed due to condition as was received the unit.The exact cause of the event experienced by the customer could not be conclusively determined.Based on the limited information available for review, vessel characteristics (while unknown) as well as procedural factors such as excessive resistance met when torquing the catheter, may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ the event "brite tip/distal tip - catheters - separated - in-patient" reported by the customer was confirmed due to the condition of the returned unit.Sem analysis showed that the catheter¿s separated areas presented material deformation and evidence of elongations.The cause of the separated condition noted could not be conclusively determined during the analysis.Based on the limited information available for review, vessel characteristics (while unknown) as well as procedural factors such as excessive torquing, may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer)¿.Neither the product history review (phr) reviews nor the product analyses suggest that the reported events could be related to the manufacturing process of the units.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH F6 ST JR 4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7427257
• MDR Text Key: 105367037
• Report Number: 9616099-2018-02053
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 532621
• Device Lot Number: 17731366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention