MAUDE Adverse Event Report: COOK INC BIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone number not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a ureteroscopy procedure, the outer sheath of the wire guide separated within the patient and the fragments were successfully removed via instruments.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of the complaint history, device history record, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device reported approximately 4.7 cm section of the device jacket material was missing starting at approximately 36 cm from the distal tip of the device.It was confirmed that portions of the outer coating had been scraped off.This device is a purchased item, and the lot acceptance report from the vendor indicated that the lot passed quality controls with no issues.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 is feasible to suggest that insufficient care was taken during the procedure to prevent damage to the coating by the device through which the wire guide was inserted.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a ureteroscopy procedure, the outer sheath of the wire guide separated within the patient and the fragments were successfully removed via instruments.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: BIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5564350
• Report Number: 1820334-2016-00213
• Device Sequence Number: 707721
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)181031(10)10593310
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: BWS-035150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 10/28/2016
• 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: 59 YR
• Patient Weight: 65