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

Model Number	7212
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented for a staged percutaneous coronary intervention (pci).The hazy target lesion was located in the non-tortuous and non-calcified previously stented obtuse marginal.A 3.00 mm x 12 mm nc emerge balloon catheter was advanced for dilatation.However, the shaft of the balloon was fractured 6 inches from the hub.The device was pulled out and the procedure was successfully completed with a different device.
Additional Manufacturer Narrative
Device evaluation by mfr: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the device.At 14.7cm from the strain relief the hypotube was separated.Contrast was present in the inflation lumen and the folds of the tightly folded balloon.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The patient presented for a staged percutaneous coronary intervention (pci).The hazy target lesion was located in the non-tortuous and non-calcified previously stented obtuse marginal.A 3.00 mm x 12 mm nc emerge balloon catheter was advanced for dilatation.However, the shaft of the balloon was fractured 6 inches from the hub.The device was pulled out and the procedure was successfully completed with a different device.

• 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: 11797147
• Report Number: 2134265-2021-05629
• Device Sequence Number: 11755472
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 12/02/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0026449935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1