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

Model Number	7213
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: used the first day of the month of aware date since there was no date provided.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the first inflation at 2 atmopheres, the balloon ruptured.The device was removed and the mid part of the shaft broke off.The procedure was completed with another of the same device.There were no complications reported and the patient was fine.
Additional Manufacturer Narrative
B3.Event date: used the first day of the month of aware date since there was no date provided.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 a complete separation at 69.9cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.The device was soaked in a water bath for three days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the first inflation at 2 atmospheres, the balloon ruptured.The device was removed and the mid part of the shaft broke off.The procedure was completed with another of the same device.There were no complications reported and the patient was fine.

• 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: 10944578
• Report Number: 2134265-2020-16797
• Device Sequence Number: 3419385
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 09/09/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025987155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1