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

Model Number	7133
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and mildly calcified mid obtuse marginal artery.A 2.25mm x 15mm emerge balloon catheter was advanced for dilatation.However, during introduction, the shaft got kinked and fractured in the distal hypotube.Subsequently, another balloon was advanced in the guide to pull the balloon out.The procedure was completed with a different device and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the non-tortuous and mildly calcified mid obtuse marginal artery.A 2.25mm x 15mm emerge balloon catheter was advanced for dilatation.However, during introduction, the shaft got kinked and fractured in the distal hypotube.Subsequently, another balloon was advanced in the guide to pull the balloon out.The procedure was completed with a different device and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 88.2cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10971526
• Report Number: 2134265-2020-17067
• Device Sequence Number: 14526904
• Product Code: LOX
• UDI-Device Identifier: 08714729806202
• UDI-Public: 08714729806202
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0025737581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention