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

Model Number	7144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since no event date provided.
Event or Problem Description
It was reported that shaft break occurred.A 1.50mm x 20mm emerge balloon catheter was advanced for dilation.However, the balloon catheter broke about 4 to 5 inches before the balloon.The device was pulled out and a different device was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 1.50mm x 20mm emerge balloon catheter was advanced for dilation.However, the balloon catheter broke about 4 to 5 inches before the balloon.The device was pulled out and a different device was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
B3.Date of event: used the first day of the month of the bsc aware date since no event date provided.Device evaluated by mfr.: the 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, contrast in the balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a hole in the shaft for 19mm starting 12.1cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11126048
• Report Number: 2134265-2020-18465
• Device Sequence Number: 19772075
• Product Code: LOX
• UDI-Device Identifier: 08714729806905
• UDI-Public: 08714729806905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 02/26/2021
• Device Model Number: 7144
• Device Catalogue Number: 7144
• Device Lot Number: 0023407846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1