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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Product code: dqx.(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
The customer reported that, while taking the cope nitinol mandril wire guide out of the artery through the needle, the wire reportedly frayed and came apart in the artery.To remedy the situation, the operator reportedly pulled the needle and the wire out together, and re-stuck the patient to finish the procedure.The customer confirmed that although the wire frayed, no part of the wire broke off into the patient at any time.No further complications were reported by the customer.The circumstances surrounding the handling and usage of the device prior to the reported product issue were not reported.The device is reportedly available for return; however, as of the date of this report, the device has not yet been received for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, instructions for use(ifu), device history record, specifications, quality control and manufacturing instructions were conducted during the investigation.The device was not returned for further investigation.However, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found one unrelated non-conformance associated with the complaint device lot number which was reworked prior to further processing.It should be noted there were no other reported complaints for this lot number.A caution label included in the packaging shows a depiction warning to not pull the distal spring coil portion of the wire guide through the needle tip.It is feasible to suggest the wire frayed ¿while taking it out of the needle.¿ based on the information provided and the results of our investigation, the root cause has been determined to be procedure related because the wire guide was withdrawn through the needle, which is against labeling provided with the device.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COPE NITINOL MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6968826
• Report Number: 1820334-2017-03593
• Device Sequence Number: 13470023
• Product Code: DQX
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)220515(10)7863410
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 01/24/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE-NT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 01/24/2018
• 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