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

Model Number G48187

Device Problems Fluid/Blood Leak (1250); Kinked (1339)

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

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) number = pre-amendment.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 that prior to making patient contact, the physician found the hub of the flexor raabe guiding sheath leaking.Additional information regarding event details, including patient anatomy and outcome, has been requested but is not available at this time.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Additional information: kinked (1339).Investigation - evaluation: a review of the functional testing, complaint history, drawings, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.Although requested, no additional event information has been received.One flexor raabe guiding sheath (kcfw-4.0-35-55-rb-raabe) was returned with a boston scientific catheter inserted through the check-flo.The hub of the boston scientific catheter was stamped ".014 / 135" on one side and "bsc 19662409 033" on the other.The length of the boston scientific catheter exiting the proximal fitting of the sheath was 91.0 cm.The dilator of the kcfw-4.0-35-55-rb-raabe was also present, but was not inserted through the sheath when returned.The boston scientific catheter was removed during examination and no damage was noted to the catheter.A kink is noted on dilator at 6.3 cm from the proximal end.The dilator was able to be fully inserted into the sheath.No damage is noted to the sheath.The device was flushed with and without the catheter and no leakage was detected.The distal end of the device was then occluded for a leak test, and when a 20cc syringe was used to inject down the side arm, fluid formed on top of the silicone disc.The check-flo cap was disassembled for further examination of the disc.The disc slit was present and centered.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7451366
• MDR Text Key: 106632850
• Report Number: 1820334-2018-01131
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)201026(10)8326075
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: G48187
• Device Catalogue Number: KCFW-4.0-35-55-RB-RAABE
• Device Lot Number: 8326075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1