MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC EXTRACTOR PRO RX RETRIEVAL CATH; ENDSCOPIC BILIARY STONE RETRIEVAL BALLOON CATH

Catalog Number M0054700

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

Balloon was tested by 3 separate endoscopy staff members prior to use.Balloon failed to inflate.Another balloon was tested and inflated ok.

• Brand Name: BOSTON SCIENTIFIC EXTRACTOR PRO RX RETRIEVAL CATH
• Type of Device: ENDSCOPIC BILIARY STONE RETRIEVAL BALLOON CATH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7510711
• MDR Text Key: 108259887
• Report Number: MW5077185
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Catalogue Number: M0054700
• Device Lot Number: 20754588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR