MAUDE Adverse Event Report: COOK INC COPE NITINOL 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	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code: dqx.Occupation: clinical risk manager.Pma/510(k) #: pre-amendment.(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
As reported a cope nitinol mandril wire guide was used in a (b)(6) female patient for a peripherally inserted central catheter (picc line) insertion procedure.User reports, "the right brachial vein was accessed using modified seldinger technique, while attempting to thread wire through the needle, resistance was met, attempt was stopped¿.Report further states, right brachial vein was accessed with new wire cope mandril wire, wire was able to be advanced.While adjusting the wire it was noted to snag on the needle.Both needle and wire were removed simultaneously.It was noted the wire had sheared at the end.Radiologist recommended x-rays of any involvement to see if there were any wire fragments.Chest x-ray and right humorous x-rays were done with no fragments noted.Because the brachial vein was the only vein large enough for a picc line, the attempt at picc line placement was aborted.A peripheral iv was started.No further adverse events have been reported in connection with this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Concomitant medical products ¿ product received on (b)(6) 2019.Investigation ¿ evaluation a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The visual inspection of the returned device showed a damaged wire and needle with biomatter on the device.The coil was elongated severely.The distal tip of the device remained undamaged, suggesting that the wire was pulled through the needle.The mandril wire od was measured and confirmed that the device was manufactured within cook¿s specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A design history record review for lot 9212194 records one non-conformance for ¿offset coils by curver¿ (qty.4), which were all scrapped.All devices with the reported rpn go through a 100% check to verify that the guide is free of surface defects and coils are not offset, and a software search for complaints on the reported lot found no additional complaints from the field.No additional devices from the reported lot were in the distribution center to be further tested.Due to this information, there is no evidence to suggest that there is nonconforming product from this lot in house or in the field.Product labeling was also reviewed.The label illustrates that withdrawal and/or manipulation of the distal spring coil of the wire guide through the needle tip may result in breakage.Based on the information provided, inspection of returned product, and the results of the investigation, a definitive cause could not be established.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.

• 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: 8513518
• Report Number: 1820334-2019-00834
• Device Sequence Number: 13943748
• Product Code: DXQ
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)231015(10)9212194
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/30/2019

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: 10/15/2023
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE-NT
• Device Lot Number: 9212194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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
• Patient Age: 76 YR