MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; STENT,METALLIC,EXPANDABLE,DUODENAL

Catalog Number M00570530

Device Problems Break (1069); Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

Event Description

A biliary stent did not deploy the way the manufacturer intended.At the time of deployment, the biliary stent deployment device malfunctioned and broke to an unusable degree.The device was removed from the scope without harm to patient or damage to scope.Manufacturer response for biliary stent, wallflex biliary rx fully covered 10mm x 60mm (per site reporter): boston scientific is investigating.

• Brand Name: WALLFLEX BILIARY
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 5732001
• MDR Text Key: 47596332
• Report Number: 5732001
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2016

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
• Device Operator: Physician
• Device Catalogue Number: M00570530
• Device Lot Number: 19060908
• Other Device ID Number: 10 MM X 60 MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 78