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

Model Number	7211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 80-90% stenosed target lesion was located in the close middle segment of right coronary artery.Following stent implantation, a 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation.However, during the procedure, the delivery shaft was fractured.The device was removed directly and the procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.At 53.5cm from the strain relief there was a kink in the hypotube.There was contrast in the inflation lumen and the balloon.The balloon was loosely folded.
Event or Problem Description
It was reported that shaft break occurred.The 80-90% stenosed target lesion was located in the close middle segment of right coronary artery.Following stent implantation, a 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation.However, during the procedure, the delivery shaft was fractured.The device was removed directly and the procedure was completed with another of same device.There were no patient complications reported and the patient 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: 12170081
• Report Number: 2134265-2021-08951
• Device Sequence Number: 11907464
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• 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): 08/19/2021

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: 06/26/2022
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0025645111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 77