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

Catalog Number KCFW-7.0-35-55-RB-HFANL0-HC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cordis 7fr guide catheter, 2.6fr cxi catheter, boston scientific magic torque guide wire.Pma/510(k) number: pre-amendment.(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

It was reported, during a left lower extremity angiogram procedure, the clear plastic interior disc of the flexor high-flex ansel guiding sheath's hemostatic valve popped through the hub and landed on the outside of the sheath.Per the complainant, the angiogram was performed via a contralateral approach with access in the right common femoral artery via the groin and the left anterior tibial artery via the foot.The complaint device was located in the groin access.At the time of the event, additional products in place through the complaint device included another manufacturer's 7 french (fr) guide catheter, a 2.6fr cxi catheter, and another manufacturer's guide wire.The physician was actively working through the access point in the foot when an audible popping sound was heard, and the hemostatic valve of the complaint device was observed to have displaced through the hub.The physician hypothesized the intravascular pressure build up resulting from the work through the foot access while the flexor high-flex ansel guiding sheath was in place, may have been too great for the valve to handle.As a result, the complaint device, cxi catheter, and guide catheter were removed over the guide wire leaving the guide wire in place and another flexor high-flex ansel guiding sheath was inserted.According to the complainant, there was minimal blood loss, described as a "drip".The patient did not experience any adverse effects as a result of this occurrence nor were any additional procedures required.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, documentation, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device noted that the silicone disc was received 8mm distal to the check-flo body of the device.Another manufacturer¿s catheter had been inserted through disc.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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 additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 7650005
• MDR Text Key: 112867295
• Report Number: 1820334-2018-01890
• 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,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1