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

Catalog Number METII-25-480

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with further information.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tracer metro direct wire guide.After a few insertions on the same patient, the wire broke off.A portion of the wire guide was left in the endoscope's working channel.Per the user, the elevator was at a normal position.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual and dimensional inspection of the wire guide was performed.The wire guide coating was empty on approximately the distal 7.0 cm, including the absence of a coil spring or core wire.Due to a lack of core wire and coil spring, the wire at the distal end was floppy and bent.A section of metal wire approximately 5.0 cm in length was also returned with the device.The section of loose metal wire has an outer diameter of approximately 0.01380" to 0.01395".For further evaluation the coating at the distal 7.0 cm was cut to expose the most distal section of core wire remaining.This section of core wire had an outer diameter of approximately 0.00900".The core wire at the distal end is ground to an outer diameter of 0.0060".Therefore the returned metal wire could not have originated from the device said to be involved.It is unknown what device the metal wire that was returned originated from.The coil spring and core wire at the distal end of the device said to be involved were not returned for evaluation.The length of the device without the cut distal end measured approximately 473.6 cm.With this section of coating included, the device measured 480.6cm.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 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.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test 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 and this represents an isolated occurrence.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.

• 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
• MDR Report Key: 11506723
• MDR Text Key: 240467526
• Report Number: 1037905-2021-00105
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002257853
• UDI-Public: (01)10827002257853(17)231109(10)W4404612
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: 11/09/2023
• Device Catalogue Number: METII-25-480
• Device Lot Number: W4404612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK DASH SPHINCTEROTOME; OLYMPUS TJF-160VR ENDOSCOPE; COOK DASH SPHINCTEROTOME; OLYMPUS TJF-160VR ENDOSCOPE