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

Model Number	7214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 20mm nc emerge balloon catheter was selected for use.However, when loading onto the wire, the body of the balloon broke.It was noted that the wire was bent prior to insertion and it snapped when attempted to strenghten it out.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 54.3cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 20mm nc emerge balloon catheter was selected for use.However, when loading onto the wire, the body of the balloon broke.It was noted that the wire was bent prior to insertion and it snapped when attempted to strenghten it out.

• Brand Name: NC 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: 10380595
• Report Number: 2134265-2020-09846
• Device Sequence Number: 16618526
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• 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): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0025325206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR