MAUDE Adverse Event Report: COOK ENDOSCOPY TRACER METRO DIRECT WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	METII-21-480
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.The coil spring is still attached to the distal end of the wire guide.Approximately 2.2 cm to 5.0 cm from the distal end, the wire guide covering has folded over itself.Approximately 5.0 cm - 9.5 cm from the distal end is a section of bare core wire.Approximately 1.1 cm of covering is hanging off of the wire guide 9.5 cm from the distal end.The wire guide has no kinks, but a few rough surfaces are found throughout the entire length of the wire guide.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include flushing the wire guide holder with thirty (30) cc of sterile water prior to removing the wire guide from the holder, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.The instructions for use for this product cautions the user that this product is compatible with non-metal tip devices.Use of the wire guide with metal tip devices may compromise the integrity of the external coating on the wire guide.The reported observation can occur if the wire guide was used with an incompatible accessory device.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tracer metro direct wire guide.The "wire coating was peeling back.".

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Common Device Name: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5684877
• Report Number: 1037905-2016-00158
• Device Sequence Number: 307592
• Product Code: OCY
• UDI-Device Identifier: 00827002268623
• UDI-Public: (01)00827002268623(17)180730(10)W3606996
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K910497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2016

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: METII-21-480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2016
• Initial Report FDA Received Date: 05/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, UNKNOWN MAKE OR MODEL