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

Model Number 7211

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: inspector, medical devices compliance verification.

Event Description

It was reported that shaft break occurred.The target lesion was located in a shunt in the left main artery.A 4.50mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.When the endoinflator went up, the shaft broke.The balloon had to be trapped out between the guide and left main to remove the device.No known patient complications were reported.

• Brand Name: NC 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8671804
• MDR Text Key: 147093925
• Report Number: 2134265-2019-06364
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846314
• UDI-Public: 08714729846314
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0022470998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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
• Patient Outcome(s): Required Intervention