MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that the spring coil of two cope stainless steel mandril wire guides unraveled when the package was opened.The event was noticed prior to patient contact.The circumstances and user handling conditions at the time of the event are not known.There are no patient consequences.The suspect devices were returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing instructions, dimensional verification, inspection of unused product, trends, device history record, complaints history, quality control data and visual inspection was conducted during the investigation.The two actual cope stainless steel mandril wire guides (lot 6516623) were not returned to the manufacturer for evaluation.15 unopened devices from the same lot number were returned for evaluation.Fourteen (14) devices were unused.One (1) device was returned with the distal tip uncoiled; the packaging was returned opened but unused.During the investigation, the distal tip of one of the wire guides was pulled intentionally until it uncoiled, requiring more than minimal force.The outer diameter of all devices was found to be in specification.Additionally, the distal tip weld was secure on all devices except for the opened device.A review of quality and manufacturing specifications confirmed that steps are in place to ensure the product is manufactured to specifications.The device history record was reviewed and no non-conformances were identified.A thorough review of complaint history search revealed that this is the only recorded complaint associated with this lot number.Based on the available information and the device not being returned, a definitive root cause could not be determined at this time.It is possible that the wire guide was met with excessive forces beyond its intended use causing it to uncoil.It is reasonable to suggest that the root cause is "product use or handling related".A quality engineering risk assessment was performed to address this failure mode.No further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6449066
• Report Number: 1820334-2017-00566
• Device Sequence Number: 19006190
• Product Code: DXQ
• UDI-Device Identifier: 00827002100770
• UDI-Public: (01)00827002100770(17)210128(10)6516623
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-125-COPE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1