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

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: lab manager.Pma/510(k) #: preamendment.(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 a cope mandril wire guide was used during a fistulogram procedure.As reported, the user advanced the wire through the sheath, and as the user pulled back the wire, it "unraveled and broke off in the patient." the patient required a cut down procedure to remove the device fragment.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
D10 - device available for return: device not available for return d11 - concomitant medical products: the wire was removed through a 4 fr micropuncture introducer.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, manufacturing instructions, and quality control of the device was conducted during the investigation.The device was not returned for investigation and no images or videos of the device were provided.However, the device from a similar complaint was reported for the same failure mode on the same device (recorded under medwatch report #1820334-2019-00989).Analysis of the returned device from this complaint revealed the wire guide was damaged, separated, and elongated at the distal end.The distal solder and tip of the wire were missing, confirming the distal portion has separated off.Dimensional analysis confirmed the device was within the correct specifications and tolerances.The investigation under the similar complaint concluded procedural issues led to the failure mode.Based on the similarities between the two complaints, it is possible that the two have the same failure mode.With the known information on the device, there is no evidence to suggest the device was manufactured out of the correct specifications and tolerances.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 for the device lot revealed three related nonconformances for damaged coil, stretched coil, overstretched coils.All affected devices were identified and scrapped out prior to lot release.The coil subassembly lots revealed no reported nonconformances.Although there were related nonconformances, the issues are visually inspected 100% during quality control.A software search revealed no other complaints have been reported for the complaint device lot.As proper inspection activities are in place, all related nonconformances were identified and scrapped out prior to release, and no other complaints have been reported for the device lot, there is no evidence to suggest there is any nonconforming product in house or out in the field.The wire guide is shipped within a wire guide holder, containing the caution label, l_scor rev 0.This label illustrates not to remove the wire guide through the needle.Based on the information provided, no returned product and the results of the investigation, user technique issues or patient anatomy likely contributed to the failure mode the appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8627983
• Report Number: 1820334-2019-01246
• Device Sequence Number: 16717553
• Product Code: DXQ
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)231116(10)9272064
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 9272064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention