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

Catalog Number	AUS-038145-DF
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that the amplatz ultra stiff ptfe double flexible wire guide began to unravel inside the ureter when feeding the wire through a "rigid" ureteroscope.The scope and device were pulled out together and no piece of the device was left in the patient.There were no reported serious injuries to the patient as a result of the reported product problem.

• Brand Name: AMPLATZ ULTRA 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: 7419423
• Report Number: 1820334-2018-01087
• Device Sequence Number: 1453204
• Product Code: OCY
• UDI-Device Identifier: 00827002535695
• UDI-Public: (01)00827002535695(17)170501(10)4953998
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/10/2018

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: AUS-038145-DF
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 106