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	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 3.50mm x 15mm nc emerge balloon catheter was advanded for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during the first inflation at 14 atmospheres for 20 seconds.
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 36.1cm distal of the strain relief.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 3.50mm x 15mm nc emerge balloon catheter was advanded for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon burst during first inflation at 14 atmospheres for 20 seconds.

• 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: 10761791
• Report Number: 2134265-2020-15051
• Device Sequence Number: 3261669
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2020

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: 10/03/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024540471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 12/12/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/22/2020; 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 55