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

Catalog Number KCFW-8.0-18/38-45-RB-ANL1-HC

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

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 an interventional procedure of the iliac, a flexor ansel guiding sheath separated from the hub at the middle of the sheath as the user was pulling back by the hub to adjust the device.The anatomy was very calcified, and resistance was reported upon removal of the sheath.The separated portion of the device was removed over an unknown wire guide without incident.The dilator was not in place at the time of separation.Another device of the same type was used to successfully 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 an interventional procedure of the iliac, a flexor ansel guiding sheath separated from the hub at the middle of the sheath as the user was pulling back by the hub to adjust the device.The anatomy was very calcified, and resistance was reported upon removal of the sheath.The separated portion of the device was removed over an unknown wire guide without incident.The dilator was not in place at the time of separation.Another device of the same type was used to successfully complete the procedure.Investigation ¿ evaluation a visual inspection and dimensional verificaion of the returned device was conducted.A document based investigation was also performed including a review of drawings, the instructions for use, manufacturing instructions, quality control data, and trends.The complainant returned kcfw-8.0-18/38-45-rb-anl1-hc used to cook for investigation with biomatter present.The check-flo valve was separated from the sheath.The inner diameter of the cap measured within specification.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Because there are no known related non-conformances and adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.Instructions for use sheath introduction 1.If the device has hydrophilic coating, activate the coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement.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.Based on the provided evidence and the completed investigation, cook has concluded device failure 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

There is no new patient or event information to report.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11362551
• MDR Text Key: 233520966
• Report Number: 1820334-2021-00378
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-8.0-18/38-45-RB-ANL1-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 104