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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.50mm x 12mm nc emerge balloon catheter was selected for use.However, during preparation, it was noted that the middle part of the shaft was fractured when the balloon catheter was removed from the carrier tube.The procedure was competed with another nc emerge.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.50mm x 12mm nc emerge balloon catheter was selected for use.However, during preparation, it was noted that the middle part of the shaft was fractured when the balloon catheter was removed from the carrier tube.The procedure was competed with another nc emerge.No patient complications were reported.It was reported via medwatch (b)(4) that the left main wire was fractured from the nc emerge balloon catheter breaking in half during the procedure.
Event or Problem Description
It was reported that shaft break occurred.A 4.50mm x 12mm nc emerge balloon catheter was selected for use.However, during preparation, it was noted that the middle part of the shaft was fractured when the balloon catheter was removed from the carrier tube.The procedure was competed with another nc emerge.No patient complications were reported.It was reported via medwatch 3600840000-2021-8093 that the left main wire was fractured from the nc emerge balloon catheter breaking in half during the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was a hypotube separation 73.5cm from the strain relief.There was contrast in the inflation lumen and balloon.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: NC 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: 12232308
• Report Number: 2134265-2021-09637
• Device Sequence Number: 3668429
• Product Code: LOX
• UDI-Device Identifier: 08714729846444
• UDI-Public: 08714729846444
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• 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,Followup
• Report Date (Section B): 10/09/2021

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: 05/03/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027241865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/26/2021; 09/23/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/12/2021; 10/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 83