MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number KCFW-5.0-35-70-RB-HFANL0-HC

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products = spectronetics laser, hydro st, terumo glide wire.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a below-the-knee intervention via access in the right common femoral artery, a flexor high-flex ansel guiding sheath became stuck.The iliac artery was "fairly" calcified and the bifurcation was reportedly high.The user attempted to pull the sheath back to start the intervention within the superficial femoral artery when the sheath stuck.The physician attempted to insert the dilator but was unable to advance it into the sheath.Another manufacturer's wire guide was then advanced through the sheath and the sheath was able to be removed and exchanged over the wire.The sheath had been in place for approximately one hour.Another manufacturer's sheath was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Description of event: as reported, during a below-the-knee intervention via access in the right common femoral artery, a flexor high-flex ansel guiding sheath became stuck.The iliac artery was "fairly" calcified and the bifurcation was reportedly high.The user attempted to pull the sheath back to start the intervention within the superficial femoral artery when the sheath stuck.The physician attempted to insert the dilator but was unable to advance it into the sheath.Another manufacturer's wire guide was then advanced through the sheath and the sheath was able to be removed and exchanged over the wire.The sheath had been in place for approximately one hour.Another manufacturer's sheath was used to complete the procedure.Investigation / evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, drawings, the instructions for use, and quality control data.The complainant returned the complaint sheath to cook for investigation.Physical examination of the returned device showed: one kcfw 5fr sheath was received used, with biomatter present.The sheath was flattened at 27.2cm from the proximal fitting and was 1.8cm in length.The dilator was not returned.No additional damage was noted.At this time, cook concluded that the device was manufactured within specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ precautions: ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ instructions for use: sheath removal: ¿2.Remove the sheath.Avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually / functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded it is possible patient anatomy contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information to report.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10867215
• MDR Text Key: 217091553
• Report Number: 1820334-2020-02150
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-5.0-35-70-RB-HFANL0-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR