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

Model Number	7133
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the initial inflation at 18 atmospherse for 7 seconds, the balloon would not stay inflated.The device was taken out and saline was flushed through the balloon port and a pinhole was noted on the balloon.The procedure was completed with a 3.0 x 20mm emerge balloon catheter.There were no patient complications reported and the patient was unharmed.
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the initial inflation at 18 atmospherse for 7 seconds, the balloon would not stay inflated.The device was taken out and saline was flushed through the balloon port and a pinhole was noted on the balloon.The procedure was completed with a 3.0 x 20mm emerge balloon catheter.There were no patient complications reported and the patient was unharmed.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely 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 was a pinhole 3mm distal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

• Brand Name: 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: 10402865
• Report Number: 2134265-2020-11085
• Device Sequence Number: 16917637
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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): 09/30/2020

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: 10/01/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0025152049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1