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

Model Number	7214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date.Event date not provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.25mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, upon inflation, the balloon ruptured.When the balloon was removed, the physician noted that it looked unusual.The procedure was completed with another of same device.There were no known patient complications nor injuries reported.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of the bsc aware date.Event date not provided.B5 - describe event or problem updated.Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The balloon was loosely folded, and the device was bloody.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, tip damage, and the outer shaft was damaged (inflated/hole) 30mm from the tip.Inspection of the rest of the device found no other damage or defect.Review of the product specification indicates the rated burst pressure of the complaint device is 20 atmospheres.The reported information indicates the device was inflated to 24 atmospheres; therefore, there is indication the device was inflated over rbp.The reported rupture was confirmed.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.25mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, upon inflation, the balloon ruptured.When the balloon was removed, the physician noted that it looked unusual.The procedure was completed with another of same device.There were no known patient complications nor injuries reported.It was further reported that the 95% stenosed target lesion was located in the calcified left circumflex coronary artery.However, during the second inflation at 24 atmospheres for 15 seconds, the device burst.Upon removal, the balloon material extended well proximal to the marker.The procedure was completed with a non-bsc device.The patient status was fine.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.25mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, upon inflation, the balloon ruptured.When the balloon was removed, the physician noted that it looked unusual.The procedure was completed with another of same device.There were no known patient complications nor injuries reported.It was further reported that the 95% stenosed target lesion was located in the calcified left circumflex coronary artery.However, during the second inflation at 24 atmospheres for 15 seconds, the device burst.Upon removal, the balloon material extended well proximal to the marker.The procedure was completed with a non-bsc device.The patient status was fine.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of the bsc aware date.Event date not provided.B5 - describe event or problem updated.

• 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: 9653249
• Report Number: 2134265-2020-00783
• Device Sequence Number: 11469212
• Product Code: LOX
• UDI-Device Identifier: 08714729846666
• UDI-Public: 08714729846666
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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 Expiration Date: 11/05/2021
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0024719217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 03/30/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/20/2020; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1