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

Catalog Number METII-25-480

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant products: sphincterotome, unknown make or model, boston scientific retriever balloon, unknown 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.A review of the device history record could not be conducted because the lot number was not provided.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 ifu states, "this device is designed for single use only.Attempts to reprocess, desterilize, and/or reuse may lead to device failure and/or transmission of disease." the report indicates that the wire guides were reused.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that devices intended to be disposable were reused; a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook tracer metro direct wire guides.The two wire guides that were used in this procedure were reused, and claimed that the distal end of the wire guide got detached and became a foreign body in the patient.The detachments occurred profoundly [sic] upon using another manufacturer's retriever balloon.The first detachment of the foreign body was retrieved endoscopically.The other detachment will be taking place [the week of (b)(6) 2019], probably also via endoscopically.No other wire guides were used in this procedure.The following information was received on 08-nov-2019: both devices were reused.The patient had stones to be extracted, so the physician wanted to use a direct visualization system.They used the cook wire guides with the extraction balloon to extract the stones.The reused wire guides were twice observed to detach when using through another manufacturer's retriever balloon.A section of the device remained inside the patient¿s body.The patient required endoscopic removal of one (1) of the two (2) detached portions with a snare.Per the initial reporter, the second detached portion was planned to be removed endoscopically the week of (b)(6) 2019.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: 9401643
• MDR Text Key: 168833890
• Report Number: 1037905-2019-00737
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: METII-25-480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF-Q180V ENDOSCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR