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

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510k status: 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
The international customer reported that during the placement by an intern, the cope nitinol mandril wire guide, into the right arm, it was discovered that the wire guide kinked 2 cm from the extremity; the guide wire perforated the patient's vein.The radiologist reportedly had to open another wire guide to continue the procedure.The wire had been inserted through and removed from an access needle.Additional procedures were reportedly not required as a result of the issue.No further information could be provided by the customer.The complaint device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
The device was returned and the file was reopened to reflect the new information from the device investigation findings.Investigation ¿ evaluation: a visual inspection/dimensional verification of the returned device were conducted during the investigation.The wire guide was returned in a used and damaged condition.The only surface damage noted was a kink approximately 2cm from the distal tip.The proximal and distal solders were intact.No elongation was noted, even upon pulling portions of the wire length-wise.It is unclear how the wire guide could have kinked by advancing rather than withdrawing, and whether the failure could be described as a kink.If the introducer needle did not fully pierce the subcutaneous tissue, it is possible that the wire guide kinked upon leaving the occluded introducer needle lumen, causing damage to nearby blood vessels.However, it was also mentioned that the wire guide was withdrawn through the needle.The ifu label warns against this action as it has a tendency to cause the wire guide to break.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined as cause traced to user (failure to follow instructions).The customer is to receive a letter of the investigation findings.The appropriate personnel were notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No new event description information to report at this time.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: after further review of the record, it was determined that it should be noted the event occurred in the patient's basilic vein.Also, additional information was received that clarified the doctor damaged the guide wire during manipulation through the needle after advancing it through the needle.Investigation - evaluation: a review of the complaint history, device history record, drawing, labeling (caution label), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation was performed.The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.A review of the device history record was performed and found two relevant instances of nonconformances in the device¿s lot (8283819).These nonconformances are unrelated however because these devices are inspected 100% and the noted nonconforming devices were scrapped during quality control.It should be noted there were no other reported complaints for this lot number.It is unclear how the wire guide could have kinked by advancing rather than withdrawing, and whether the failure could be described as a kink.If the introducer needle did not fully pierce the subcutaneous tissue, it is possible that the wire guide kinked upon leaving the occluded introducer needle lumen, causing damage to nearby blood vessels.However, it was also mentioned that the wire guide was withdrawn through the needle.The label warns against this action as it has a tendency to cause the wire guide to break.Based on the information provided, no product returned and the results of our investigation, the possible root cause is attributed to product use or handling related (user technique).We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 7327597
• Report Number: 1820334-2018-00605
• Device Sequence Number: 16545664
• Product Code: DXQ
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)221025(10)8283819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2018

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 Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE-NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 05/25/2018; 08/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 06/21/2018; 09/17/2018
• Patient Sequence Number: 1