MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 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 Problems Gastrointestinal Hemorrhage (4476); Pancreatitis (4481)

Event Date 07/16/2022

Event Type  Injury  

Manufacturer Narrative

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.However, a device failure was not reported in the article.The instructions for use include the following potential complications: "potential adverse events associated with ercp.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.Citation: pereira lima jc et.Al.Feasibility of endoscopic papillary large balloon dilation to remove difficult stones in patients with nondilated distal bile ducts.World j gastrointest endosc 2022; 14(7): 424-433 url: https://www.Wjgnet.Com/1948-5190/full/v14/i7/424.Htm doi: https://dx.Doi.Org/10.4253/wjge.V14.I7.424.

Event Description

Cook became aware of a clinical literature article involving cook tracer metro direct wire guides.Please see below for relevant excerpts of this article: data were retrieved and analyzed from 1289 ercps conducted in two prospective trials during 2014-2019 that assessed post-ercp pancreatitis (pep) prevention.A complete sphincterotomy was performed via the papillary ostium or the access obtained after pre-cut papillotomy (triatome triple lumen sphincterotome 25 mm [captured in separate report], tracer metro direct wire guide [subject of this report], huibregtse triple lumen needle knife 4 mm [captured in separate report], cook endoscopy, winston-salem, nc, united states).The primary outcome was ercp complications, notably perforation and pancreatitis (pep).The complication rate was similar in both groups.Eight of 113 (7.1%) patients with a nondilated distal duct had complications (two had perforations, three had overt bleedings, and three had pep), while five of the 78 (6.4%) patients with a large distal duct who received an eblbd had complications (two had bleeding, one experienced cholangitis, and two had pep).All complications were treated conservatively, and no patients died from the procedure.An ex vivo porcine model showed that biliary duct tears are caused by overdistention of narrow ducts after large balloon dilation.5 - post ercp pancreatitis 5 - overt bleeding 1 - cholangitis" subsequent emdr reports will be sent to capture the other two devices said to be involved.It was not reported if a section of the device remained inside the patient¿s body.All complications were treated conservatively, and no patients died from the procedure.No further information was provided in the article.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 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: 18887259
• MDR Text Key: 337457257
• Report Number: 1037905-2024-00146
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention