MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7132

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.During a st-elevation myocardial infarction procedure, a 2.50mm x 12mm emerge balloon catheter was used for dilatation.However, the shaft of the balloon broke.The device was retrieved and no patient complications were reported.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11029386
• MDR Text Key: 222118068
• Report Number: 2134265-2020-18029
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2023
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0026038065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1