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

Catalog Number	HYB-48015
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: extraction balloon, unknown make or model.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use for this product line instruct the user to flush the wire guide prior to removal from the wire guide holder.This activity will aid in optimal performance of the wire guide.Failure to flush the wire guide can result in damage to the wire guide.The instructions for use for this product line instruct the user to flush endoscope accessory channel and /or lumen of device with sterile water and for best results, wire guide should be kept wet.This activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel can result in damage to the wire guide.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 hybrid wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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 hybrid wire guide.The wire guide is stuck inside of the balloon catheter and ripped off the main wire [core wire].The wire guide stripped at the distal end.A piece of plastic cover [coating] broke off and ended up in the catheter, the piece was retrieved.Its unknown at what point this occurred.The customer confirmed the elevator was down.
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 0.0 cm to 8.2 mm from the distal end, the wire guide covering has folded over itself.The folded over portion of covering has split in multiple areas.Approximately 8.2 cm to 16.5 cm from the distal end is a section of bare core wire.The wire guide covering feels rough approximately 151.0 cm to 162 cm from the distal end.There are no kinks or additional rough surfaces along the wire guide.A section of coating approximately 1.8 cm long was returned that was separated from 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 evaluation: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use for this product line instruct the user to flush the wire guide prior to removal from the wire guide holder.This activity will aid in optimal performance of the wire guide.Failure to flush the wire guide can result in damage to the wire guide.The instructions for use for this product line instruct the user to flush endoscope accessory channel and/or lumen of device with sterile water and for best results, wire guide should be kept wet.This activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel can result in damage to the wire guide.The instructions for use for this product caution 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 hybrid wire guides are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: 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.

• Brand Name: TRACER HYBRID 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: 5514083
• Report Number: 1037905-2016-00063
• Device Sequence Number: 146058
• Product Code: OCY
• UDI-Device Identifier: 00827002226593
• UDI-Public: (01)00827002226593(17)181120(10)W3653044
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2016
• Report Date (Section F): 03/01/2016

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: HYB-48015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/25/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 04/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 73
• Date Report Sent to FDA: 03/01/2016