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

Catalog Number KCFW-6.0-38-70-RB-RAABE

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

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, the hub of a flexor raabe guiding sheath had a crack in it and was leaking blood.Access was gained in the groin, below the knee.The patient was noted to have moderate tortuous, calcified, or scarred anatomy.They continued using the complaint device to complete the case.No unintended section of the device was inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

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, the hub of a flexor raabe guiding sheath had a crack in it and was leaking blood.Access was gained in the groin, below the knee.The patient was noted to have moderate tortuous, calcified, or scarred anatomy.They continued using the complaint device to complete the case.No unintended section of the device was inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

Manufacturer Narrative

Summary of event: as reported, the hub of a flexor raabe guiding sheath had a crack in it and was leaking blood.Access was obtained in the groin and the target location was below the knee.The patient was noted to have moderate tortuous, calcified, or scarred anatomy.They continued using the complaint device to complete the case.No unintended section of the device was inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook could not complete a review of the device history record due to a lack of lot information from the user facility.A global shipment search on the user facility could not definitively determine the lot number for the complaint device.At this time, cook could not conclude that nonconforming product from the affected lot exists in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: potential adverse events ¿bleeding¿ how supplied ¿upon removal from package, inspect the product to ensure no damage had occurred.¿ the information provided upon review of the dmr and the ifu suggest that there is no evidence the device was manufactured out of specification.Based upon the available information and results of the investigation, cook has concluded that a component failure unrelated to manufacturing contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Information was available but incorrectly reported on the previous report.Access was obtained in the groin and the target location was below the knee.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13543111
• MDR Text Key: 286146604
• Report Number: 1820334-2022-00235
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-38-70-RB-RAABE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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