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

Catalog Number	HWA-035150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
During an unspecified procedure, the hiwire nitinol hydrophilic wire guide was used and it was noted that the glide wire was stripped.Another of the same was used to complete the procedure with no harm to the patient.As reported no unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.There were no adverse effects or consequences to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, device history record, documentation, instructions for use and specifications was completed during this investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.The lot number provided is not a cook lot number therefore no device history record can be completed at this time.Lot number provided was not a cook number.No serial number was provided.If the information is provided the file will be updated.Based on the available information, a definitive root cause could not be determined.Appropriate personnel have been notified and will monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: HIWIRE 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: 6865230
• Report Number: 1820334-2017-02974
• Device Sequence Number: 13631238
• Product Code: OCY
• UDI-Device Identifier: 00827002304819
• UDI-Public: (01)00827002304819(17)200223(10)10804099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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 Catalogue Number: HWA-035150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1