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

Model Number G32373

Device Problem Split (2537)

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

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(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 that during implantation of another manufacturer's iliac stent graft, the surgeon tried to gain access back into the recently deployed stent as it had moved.Prior to re-insertion of the flexor guiding sheath, it was observed that the dilator had split; therefore, the sheath was not used.The sheath was reported to have been previously utilized.An angiogram, iliac stenting, and an angioplasty were performed; the case was able to be successfully completed.Another manufacturer's sheath followed by the flexor guiding sheath with check-flo valve, wire guide (manufacturer unspecified), and the iliac stent graft were utilized.Access to the aneurysm was gained via bilateral (right and left) groin puncher.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

Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a 2 mm split at the tip of the device.No other damage was noted to the device.The dilator accepted a 0.038¿ wre guide, but the split in the tip prevented a smooth transition.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.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.

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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7306889
• MDR Text Key: 101524807
• Report Number: 1820334-2018-00559
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002323735
• UDI-Public: (01)00827002323735(17)200404(10)7800521
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: G32373
• Device Catalogue Number: KCFW-12.0-38-40-RB
• Device Lot Number: 7800521
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PYRAMED BEGRAFT STENTAVANTI SHEATHWIRE GUIDE UNK
• Patient Age: 80 DA