MAUDE Adverse Event Report: Wilson-Cook Medical Inc FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Model Number	G31537
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING
• Common Device Name: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
• Manufacturer (Section D): Wilson-Cook Medical Inc; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): Wilson-Cook Medical Inc; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; +1(336)744-0157
• MDR Report Key: 50882444
• Report Number: 1037905-2026-00577
• Device Sequence Number: 13218269
• Product Code: GCA
• UDI-Device Identifier: 00827002315372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: G31537
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W5025983
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown