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

Model Number	G25686
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A black section of coating approximately 5.2 cm long was returned that was separated from the wire guide.Approximately 0.0 cm to 3.6 cm from the distal end is a section of bare core wire.The coil spring is still attached to the distal end of the wire guide and is stretched.The stretched portion of the coil spring begins approximately 1.9 cm from the distal tip and extends approximately 49.7 cm.No kinks or rough surfaces are found along 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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.Prior to distribution, all cook tracer metro direct 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: 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 physician wanted to cannulate by using another manufacturer's device and a metii-35-480.The assistant nurse opened the package of the met ii-35-480 and flushed.When the nurse tried to put the wire in the port, a portion of the coating tip was detached from the guide wire [prior to endoscope contact].The nurse opened the new one and it was used.Further information was received on 09-september- 2018: the location of the damage occurred at the patient end, in the black coated tip.This occurred prior to patient contact; there was no impact to the patient.

• 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: 7901527
• Report Number: 1037905-2018-00434
• Device Sequence Number: 13495176
• Product Code: OCY
• UDI-Device Identifier: 00827002256866
• UDI-Public: (01)00827002256866(17)210416(10)W4055735
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K910497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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 Expiration Date: 04/16/2021
• Device Model Number: G25686
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4055735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1