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

Model Number	7143
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation under nominal pressure, the balloon ruptured.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation under nominal pressure, the balloon ruptured.There were no patient complications and the patient was stable.It was further reported that the target lesion was located in the left circumflex aartery.The device was removed and the procedure was completed with another of the same device.
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, and blood in the guidewire lumen.The balloon was loosely folded.There was a pinhole 21mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during inflation under nominal pressure, the balloon ruptured.There were no patient complications and the patient was stable.It was further reported that the target lesion was located in the left circumflex artery.The device was completely removed and the procedure was completed with another of the same device.

• 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: 10750325
• Report Number: 2134265-2020-14944
• Device Sequence Number: 19584845
• Product Code: LOX
• UDI-Device Identifier: 08714729806790
• UDI-Public: 08714729806790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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): 12/06/2020

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: 11/20/2021
• Device Model Number: 7143
• Device Catalogue Number: 7143
• Device Lot Number: 0024806914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/20/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/05/2020; 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR