MAUDE Adverse Event Report: COOK INC SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSCF-35-260-3
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx (b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during a heart catherization, the safe-t-j exchange fixed core wire guide was inserted and removed once through the catheter.When the physician attempted to perform a catheter exchange and was getting ready to input the wire guide a second time, a hair-like fragment unraveling from the wire guide was observed.No portions of the wire guide remained inside of the patient's anatomy.Another safe-t-j exchange fixed core wire guide was used to successfully complete the procedure.It was noted that there was no calcium buildup present; no resistance was encountered during the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that no signs of unraveling and/or separation of the wire guide were evident.The fiber visible in the check-in photos was not a component of the wire guide.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, it was determined that the product functioned as intended.As there was no evidence to suggest device failure, and the returned complaint device shows no damage, no risk assessment was performed in this case.We will continue to monitor for similar complaints.
Additional Manufacturer Narrative
During evaluation of the complaint device, it was observed that the hair-like fragment did not originate from the wire guide.The fragment is a long, stringy and clear plastic ribbon that appears to be delamination of the catheter utilized with the wire guide.Per the initial reporter (received 7feb2018), another manufacturer's diagnostic five (5) fr catheter was used during the procedure.Another catheter was utilized to complete the procedure as the safe-t-j exchange fixed core wire guide was thought to be defective.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7228605
• Report Number: 1820334-2018-00335
• Device Sequence Number: 16512855
• Product Code: DQX
• UDI-Device Identifier: 00827002005174
• UDI-Public: (01)00827002005174(17)220510(10)7815655
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: TSCF-35-260-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/05/2018; 03/12/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/09/2018; 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1