MAUDE Adverse Event Report: CORDIS CORPORATION 5F10CM SW RADIAL; INTRODUCER, CATHETER

Model Number 506510S

Device Problems Break (1069); Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18068607 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.

Event Description

As reported, the last piece of the the 5f 10cm rain sheath was noted to be stuck in the vessel when removing.After removal from the patient, it was noted that the last 0.5cm of the tip was damaged.It was confirmed that there was no damage to the sheath prior to inflating the tr band.There was no difficulty using the sheath during the procedure, prior to inflating the tr band.There was no reported injury to the patient.This occurred at the end of the procedure, after the tr-band was inflated and the sheath was being removed.The tr-band was deflated; however it did not recover its original shape.The sheath was removed with a quick movement, and the tr -band was inflated again.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: as reported, the last piece of the 5f 10cm rain sheath was noted to be stuck in the vessel when removing.After removal from the patient, it was noted that the last 0.5cm of the tip was damaged.It was confirmed that there was no damage to the sheath prior to inflating the tr band.There was no difficulty using the sheath during the procedure, prior to inflating the tr band.There was no reported injury to the patient.This occurred at the end of the procedure, after the tr-band was inflated and the sheath was being removed.The tr-band was deflated; however, it did not recover its original shape.The sheath was removed with a quick movement, and the tr -band was inflated again.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.The device was returned for analysis.One non-sterile unit of 5f10cm sw radial was received inside of a clear plastic bag.Per visual inspection, only the catheter sheath introducer was returned for analysis.A kinked/bent condition was found on the cannula located approximately at 0.7 and 10.1 cm from distal the tip.No other anomalies were observed by the naked eye on the returned unit.Per dimensional analysis of the catheter inner and outer diameter, measurements were taken near the damages found.The measurements were verified against the ppe specification and were found to be within specification.A product history record (phr) review of lot 18068607 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as " catheter sheath introducer (csi) - withdrawal difficulty¿ could not be properly evaluated and confirmed due the nature of the complaint.Two kinked areas were observed on the catheter sheath introducer.With the limited information provided and without video of the use of the transradial band during the sheath withdrawal attempt a clinical conclusion cannot be definitively made.However, there are device interactions, such as proper positioning of the band and withdrawing the sheath to a designated estimation, prior to inflating the balloon that may have contributed to the difficulties reported by the customer.Additional steps include slowly inflating the balloon of the band while simultaneously removing the sheath.If the balloon is inflated to capacity prior to the sheath exiting the artery, this can lead to withdrawal difficulty and kinking of the sheath.As there was no evidence of kinking prior to the inception of the band, there are likely device interaction and/or user /handling factors that may have contributed to the reported events.Other factors, such as appropriate sheath size for the vessel.According to the instructions for use (ifu), although not intended as a mitigation of risk, it precautions to confirm, prior to use, that the sheath size is appropriate for the access vessel to be used.The ifu also precautions that if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.Under instructions for use, once all catheters and wires are removed, remove the sheath when clinically indicated by placing compression on the vessel above the puncture site and slowly withdraw he csi.Based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported, the last piece of the the 5f 10cm rain sheath was noted to be stuck in the vessel when removing.After removal from the patient, it was noted that the last 0.5cm of the tip was damaged.It was confirmed that there was no damage to the sheath prior to inflating the tr band.There was no difficulty using the sheath during the procedure, prior to inflating the tr band.There was no reported injury to the patient.This occurred at the end of the procedure, after the tr-band was inflated and the sheath was being removed.The tr-band was deflated; however it did not recover its original shape.The sheath was removed with a quick movement, and the tr -band was inflated again.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: 5F10CM SW RADIAL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15109234
• MDR Text Key: 301262591
• Report Number: 9616099-2022-05850
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10705032078917
• UDI-Public: (01)10705032078917(17)241031(10)18068607
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K181592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 506510S
• Device Catalogue Number: 506510S
• Device Lot Number: 18068607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TR BAND-COMPRESSION DEVICE