MAUDE Adverse Event Report: COOK INC AMPLATZ STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number THSF-35-260-ASG

Device Problem Flaked (1246)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Pro code=dqx.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, the veterinarian was performing a balloon valveplasty on a male dog and the amplatz stiff support wire guide was used.The initial reporter stated the wire guide kinked when introduced into the dog.It was also noted that where the wire guide kinked the green coating flaked off.Reportedly, none of the coating was noted as being retained in the dog's anatomy.Another wire guide was used to complete the procedure.According to the initial reporter, the animal did not experience any adverse effects as a result of this occurrence and is reportedly doing well.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable, or unchanged.Additional information b5: it was reported that this procedure was performed on a patient with severe pulmonic stenosis, with no abnormalities to the pulmonary artery." additionally, a percutaneous 4 french right judkins balloon catheter was used in conjunction with our cook device during the procedure.This balloon catheter was not withdrawn through the needle.The initial reporter noted a large amount of resistance when trying to remove the balloon catheter from the patient.The device had to be removed at the same time as the wire.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, quality control, specification, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that 2mm of coating was absent distal to the kink.It also revealed that the kink located 12.9cm from the distal end, felt sharp.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 two nonconforming events which could contribute to this failure mode.The first nonconformances (2 devices) was for bent/kinked device and relevant to the device failure mode.The second nonconformances was for foreign matter and not relevant for the device failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control records revealed no gaps in the process instructions.Moreover, the dog had pulmonic stenosis and there was resistance attempting to remove the balloon catheter from the patient.It is not known if balloon catheter was compatible with the wire used or if it met it¿s manufacturing quality specifications, and there is no evidence to suggest the cook product was damaged upon opening.Therefore, based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause cannot be traced to the device, and may lie with the patient condition or procedure process.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.

• Brand Name: AMPLATZ STIFF SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7878608
• MDR Text Key: 120539713
• Report Number: 1820334-2018-02674
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Catalogue Number: THSF-35-260-ASG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1