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

Model Number	7312
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation but the balloon ruptured during inflation.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
D4: corrected batch/lot number from 24767323 to 24767327.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation but the balloon ruptured during inflation.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
D4: corrected batch/lot number from 24767323 to 24767327.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 was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.There was a pinhole at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation but the balloon ruptured during inflation.The procedure was completed with another of the same device.There were no patient complications 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: 11158021
• Report Number: 2134265-2021-00241
• Device Sequence Number: 10914551
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 11/13/2021
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0024767327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 03/05/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/04/2021; 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1