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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80-90% stenosed target lesion was located in the severely calcified middle of right coronary artery.A 3.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, it was noticed that the delivery shaft was fractured.The device was completely removed without any issue noted and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen.And the balloon was tightly folded.There was a hole in the inner shaft 37mm from the tip.And a hole in the outer shaft 39mm from the tip.The damage was consistent with and interaction with a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported, that shaft break occurred.The 80-90% stenosed, target lesion was located in the severely calcified middle of right coronary artery.A 3.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, it was noticed, that the delivery shaft was fractured.The device was completely removed without any issue noted.And the procedure was completed with another of the same device.There were no patient complications nor injuries reported.And the patient's status was stable.

• 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: 11409019
• Report Number: 2134265-2021-01795
• Device Sequence Number: 19827526
• Product Code: LOX
• UDI-Device Identifier: 08714729846536
• UDI-Public: 08714729846536
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 05/30/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0023881299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 55