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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
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 shaft break occurred.A 2.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, the shaft broke at the middle portion before entering the patient's body.The procedure was completed with a different device.No patient complications were noted.
Additional Manufacturer Narrative
B3 - event date: corrected from (b)(6) 2020 to (b)(6) 2020.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm nc emerge balloon catheter was selected for dilatation.However, before the balloon went in the patient, mid shaft break was noted.The procedure was completed with another of same device which worked fine.No patient complications were noted.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm nc emerge balloon catheter was selected for dilatation.However, before the balloon went in the patient, mid shaft break was noted.The procedure was completed with another of same device which worked fine.No patient complications were noted.
Additional Manufacturer Narrative
B3: event date: corrected from (b)(6) 2020.D4: lot number: corrected from 24917385 to 26314766.D4: expiration date: correction from 12/11/2021 to 11/06/2022 h4: device manufacture date corrected from 12/12/2019 to 11/06/2020.Device evaluation 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 80.4cm distal of the strain relief.The balloon was tightly folded.Microscopic inspection revealed tip damage.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: 11155327
• Report Number: 2134265-2021-00060
• Device Sequence Number: 16791798
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/17/2021

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: 11/06/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026314766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 02/02/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/27/2021; 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1