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

Catalog Number METII-35-480

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The wire guide is bent at approximately 4.5c m from the distal end.Rough spots on the coating were also found throughout the length of the wire guide.When functionally tested with a compatible cook sphincterotome, slight resistance was felt while advancing wire guide.No other anomalies were detected with the device.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 for use instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.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 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.The physician advanced the device to the desired position and felt obvious resistance while exchanging the sphincterotome through the wire guide.The physician retracted the sphincterotome and the wire guide from the patient, and changed to another one of the same wire guide to complete the procedure.This event was not reportable at this time.Clarifying information received 31-aug-2020 that the wire guide and sphincterotome were both removed because the wire guide became stuck and was unable to move [loss of wire guide access, subject of the report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 10597334
• MDR Text Key: 218728451
• Report Number: 1037905-2020-00412
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002256863
• UDI-Public: (01)10827002256863(17)230414(10)W4340141
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4340141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 58