MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent an unknown procedure using a amplatz extra stiff ptfe double flexible wire guide.The attending physician indicated that the wire became unraveled while removing the device from the patient.The physician stated the tip is missing and is uncertain if the tip or coating was left inside the patient.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, dimensional verification, device history record, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the amplatz extra stiff ptfe double flexible wire guide noted the wire to be separated into two pieces with piece 1, noted to be longer in length than piece 2, and kinks at three locations along the length of the wire.Coil elongation was present.The weld ball was noted at the distal tip of piece 2.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation this type of device failure has generally been associated with the wire guide being damaged by withdrawal and/or manipulation through the needle or other instrument.Less frequently, patient anatomy is known to make withdrawal of the wire guide difficult, resulting in damage when the force applied exceeds design specifications.The most likely root cause; however, could not be definitively determined in this case.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• Brand Name: AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6310383
• Report Number: 1820334-2017-00189
• Device Sequence Number: 11006823
• Product Code: OCY
• UDI-Device Identifier: 00827002535640
• UDI-Public: (01)00827002535640(17)181223(10)6425514
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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 Model Number: N/A
• Device Catalogue Number: AES-038145-DF
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 05/08/2017
• 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: Other