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

Model Number	7212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a non-tortuous and non-calcified vessel.A 2.75mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used the 1st day of the month of the bsc aware date as no event date was provided.Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The balloon was torn 8mm circumferential and longitudinally pulled over tip.There were numerous kinks throughout the catheter.The burst section most likely became caught on the lesion or another device during withdrawal from the patient.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a non-tortuous and non-calcified vessel.A 2.75mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.No patient complications were reported.

• 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: 9404017
• Report Number: 2134265-2019-14779
• Device Sequence Number: 14065988
• Product Code: LOX
• UDI-Device Identifier: 08714729846383
• UDI-Public: 08714729846383
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/14/2020

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 Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0024270847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1