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

Model Number	7133
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Coronary angiography was performed in the catherization lab and it was noted that there was a plaque infiltration in the proximal and middle of left anterior descending artery without significant stenosis.Diagnostic imaging shows an occlusion in the proximal end, with obvious calcification, and another branch was found in the occlusion, and plaques were found in the proximal end of the branch.There was no stenosis observed in the proximal left circumflex artery, while plaque infiltration in the middle with about 20-30% stenosis.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation at 10 atmospheres for 5 seconds, the calcification punctured the balloon.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.

• 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: 12105119
• Report Number: 2134265-2021-08466
• Device Sequence Number: 4601240
• Product Code: LOX
• UDI-Device Identifier: 08714729806189
• UDI-Public: 08714729806189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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
• Report Date (Section B): 07/01/2021

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: 01/01/2023
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0025493722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 85