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

Model Number	7213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during second inflation, the balloon ruptured.No further patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during second inflation, the balloon ruptured.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and balloon.The balloon was loosely folded, and the device had tip damage.The device was soaked for a period of time and then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 7mm from the tip of the device.The device failed to inflate to rated burst pressure.Product analysis confirmed the reported event, as the device was found to have a pinhole damage to the balloon.

• 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: 12027042
• Report Number: 2134265-2021-07864
• Device Sequence Number: 1374949
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 03/27/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0027046229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1