MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MWB-3X6

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

Patient Problems Gastrointestinal Hemorrhage (4476); Pancreatitis (4481)

Event Type  Injury  

Event Description

Cook became aware of the clinical literature article involving cook memory hard wire baskets."from january 2013 to january 2019, a total of 1555 consecutive patients diagnosed with cholecystolithiasis combined with choledocholithiasis who underwent surgical treatment in tongji hospital were retrospectively analyzed." "[ercp group]following deep cannulation, retrograde cholangiography, sphincterotomy or balloon expansion (wilson-cook tx-15-a), the cbd stones were extracted by a basket (wilson-cook mwb-3x6) until no stones were confirmed by repeat cholangiogram.Mechanical lithotripsy was used to retrieve the stones if needed." "there were more postoperative complications in ercp + lc group (3.6%)"."five patients (4 in ercp + lc group and 1 in tri-scope group) with pancreatitis recovered with conservative treatment.Three cases appeared with hemorrhage in ercp + lc group, of which two patients were well-healed with hemostatic and fluid therapy, and one patient was cured with interventional therapy.Totally 8 patients (0.8%) developed bile leakage and recovery after drainage within 1¿3 days during hospitalization." "no patient converted to open surgery in three groups." postoperative complications: outcomes of patients with cholecystolithiasis combined with choledocholithiasis ercp+lc (n= 275), pancreatitis (%) 4 (1.5), bile leak (%) 0 (0.0), bleeding (%) 3 (1.1), cholangitis (%) 3 (1.1).Outcomes of ercp + lc group and tri-scope group: ercp + lc (n= 275) tri-scope (n = 479) p postop complications 10 (3.6) pancreatitis (%) 4 (1.5) 1 (0.2) 0.118 bile leak (%) 0 (0.0) 5 (1.0) 0.174 bleeding (%) 3 (1.1) 3 (0.6) 0.791 cholangitis (%) 3 (1.1).Outcomes of ercp + lc group and ltcbde group: ercp + lc(n = 275) ltcbde(n = 280) p postop complications 10 (3.6) 3 (1.1) ¿ pancreatitis (%) 4 (1.5) 0 (0.0) 0.128 bile leak (%) 0 (0.0) 3 (1.1) 0.257 bleeding (%) 3 (1.1) 0 (0.0) 0.241 cholangitis (%) 3 (1.1).Intervention was required as noted in the article but as also noted in the article, "no patient converted to open surgery in three groups." the subject of this report are the four (4) events of pancreatitis, three (3) events of bleeding, and three (3) events of cholangitis.

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, only post procedure complications.Pancreatitis, cholangitis, and bleeding are known complications of gastrointestinal endoscopy and ercp.The ifu lists potential complications: "those associated with gastrointestinal endoscopy and ercp include, but are not limited to: pancreatitis, cholangitis, sepsis, perforation, hemorrhage, aspiration, fever, infection, hypotension, allergic reaction, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all memory hard wire baskets are subjected to a visual inspection and functional testing 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.Guo t, wang l, xie p, zhang z, huang x, yu y.Surgical methods of treatment for cholecystolithiasis combined with choledocholithiasis: six years' experience of a single institution.Surg endosc.2022 jul;36(7):4903-4911.Doi: 10.1007/s00464-021-08843-x.Epub 2021 nov 3.Pmid: 34731303; pmcid: pmc9160127.

• Brand Name: MEMORY HARD WIRE BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• 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: 17661585
• MDR Text Key: 322394492
• Report Number: 1037905-2023-00410
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/31/2023

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: MWB-3X6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Outcome(s): Required Intervention