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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not provided at the time of reporting.The first date of the month of the aware date was selected.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 20mm emerge balloon catheter shaft broke during the procedure.The device was removed intact and the procedure was competed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There were numerous hypotube and shaft kinks to the device.At 105.4cm from the strain relief the inflation lumen was separated distal to the midshaft bond that connects the inflation lumen to the hypotube of the device.The separated ends were jagged and visibly torn.The distal separated portion was 37.5cm in length which included the inflation lumen, exit notch, guidewire lumen, balloon, and tip.There was contrast and blood present in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded, and contrast was present in the balloon.Product analysis confirmed the reported break as there was separation of the device.There were also numerous unreported kinks.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 20mm emerge balloon catheter shaft broke during the procedure.The device was removed intact and the procedure was competed with a different device.There were no patient complications reported.

• 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: 12207588
• Report Number: 2134265-2021-09384
• Device Sequence Number: 4440493
• Product Code: LOX
• UDI-Device Identifier: 08714729806332
• UDI-Public: 08714729806332
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 06/09/2023
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0026167479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1