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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 09/15/2017

Event Type  Injury  

Event Description

The following was reported to cook endoscopy via a clinical literature article involving cook tracer metro direct wire guides."this single-center, prospective, randomized study was conducted at ajou university hospital between december 2014 and december 2015.Patients with intact papilla and pancreaticobiliary disease who were candidates for therapeutic biliary ercp were invited to participate in the study.192 patients fulfilled the eligibility criteria and were enrolled in the study.The patients were randomized into groups that underwent ercp with sgw (n = 96).Selective bile duct cannulation was performed by the standard wgc technique with a selective bile duct cannulation was performed by the standard wgc technique with a 0.035-inch guidewire (in the sgw group: tracer metro direct wire guide; wilson-cook medical inc., winston-salem, nc, usa).Pep was defined as an elevation in plasma amylase of 3 times or more above the upper reference limit and the presence of abdominal pain persisting for 24 h after the procedure.Serum amylase levels were checked at 4 and 24 h after ercp to monitor pep in all patients.Pep developed in 8.3% (seven patients with mild and one patient with severe) of the patients in the sgw group (p = 0.567) [subject of this report]." it was not published if a section of the device remained in the patient's body.The patients experienced post-ercp pancreatitis (pep).The treatment for the pep was not published, but it is assumed out of caution that intervention was performed.

Manufacturer Narrative

This event from literature is under investigation.A final emdr will be provided.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the products said to be involved were 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 products said to be involved were not returned for evaluation.A definitive cause for the reported observation could not be determined.A device failure was not identified in the article, only post procedure complications.The ifu lists the potential complications: "potential adverse events associated with ductal cannulation and bridging of strictures include, but are not limited to: perforation, pancreatitis, bleeding or tissue inflammation." prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test to ensure device integrity.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.

• 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12715942
• MDR Text Key: 284478875
• Report Number: 1037905-2021-00596
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 11/23/2021
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF ENDOSCOPE.
• Patient Outcome(s): Required Intervention