MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
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 ureteroscopy procedure using an standard fixed core wire guide.The attending physician indicated that while performing this procedure the wire frayed.A piece of the wire had to be retrieved from the patient.No unintended sections of the device remained inside the patient¿s body nor did the patient experience any additional procedures or adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: device was returned for the evaluation.A visual examination discovered the distal weld connection has separated from the safety wire, resulting in coil elongation and wire protrusion.Approximately 7mm of the coil located at the distal end was not elongated.The overall length of the coil that did exhibit coil elongation measured approximately 133.5 cm.Although damage to the wire was confirmed, both weld connections were intact, indicating that no material was left within the patient.It was concluded that the device had been subjected to force beyond its intended design.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.In addition, the review of device history record did not observe any nonconformance that may have contributed to this incident.A complaint history review showed this complaint to be the only one associated with the complaint lot number.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6312059
• Report Number: 1820334-2017-00299
• Device Sequence Number: 10771913
• Product Code: OCY
• UDI-Device Identifier: 00827002145900
• UDI-Public: (01)00827002145900(17)190401(10)6860195
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 635497
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 04/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention