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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Pma/510(k) number = pre-amendment.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One safe-t-j exchange fixed core wire guide was returned for investigation.Wire guide core wire and safety wire are exposed at the distal end.Coil has 1 mm elongation noted 3.5 mm form distal end.Coil is off set 13.6mm, 14.6mm and 15.9mm from the distal end.Safety wire is protruding 0.5 mm at 2.1cm from the distal end.Bend is noted 2.3cm from the distal end.Elongation noted from 2.3cm to 3.8cm from the distal end.Core and safety wires are exposed 13.4cm from the distal end.Core is exposed; length is 1.6cm.Safety wire is exposed; length is 2.5cm.Safety wire is separated into two segments.Mandril wire was examined for defects and damage and no non-conformities were noted.Tip and back welds were smooth, not sharp or offset and mandril is securely caught.The coil and mandril outer diameter measured within specifications.The safety wire thickness and width measured within specifications.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.
Event or Problem Description
It was reported, the wire core is protruding approximately 8cm from the tip of the safe-t-j exchange fixed core wire guide prior to patient contact.No adverse effects have been reported.

• 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: 7938217
• Report Number: 1820334-2018-03013
• Device Sequence Number: 11090647
• Product Code: DQX
• UDI-Device Identifier: 00827002005174
• UDI-Public: (01)00827002005174(17)230731(10)9019504
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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 Expiration Date: 07/31/2023
• Device Catalogue Number: TSCF-35-260-3
• Device Lot Number: 9019504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1