MAUDE Adverse Event Report: BOSTON SCIENTIFIC ETRACTOR XL; CATHETER, BILIARY, SURGICAL

Model Number 4712

Device Problem Deflation Problem (1149)

Patient Problem Bowel Perforation (2668)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

The team used a boston scientific balloon to sweep the common bile duct.As the balloon was being deflated by aspirating the air with the enclosed syringe from kit, the balloon did not deflate.Multiple attempts were used to deflate the balloon with different syringe and pulling, the balloon finally deflated on its own.The physician noticed a small tear in bile duct which required stent placement.
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manufacturer response for extractor pro xl, boston scientific (per site reporter)
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• Brand Name: ETRACTOR XL
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; one boston scientific place; natick MA 01760
• MDR Report Key: 4109342
• MDR Text Key: 17619025
• Report Number: 4109342
• Device Sequence Number: 1
• Product Code: GCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 4712
• Device Lot Number: 17030101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 27 YR