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

Model Number	7214
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date the incident occurred was estimate as 01-aug-2019 which is the first day of the month of the aware date.
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during inflation at 24 atmospheres, the shaft broke.Removal difficulty was noted so an optical coherence tomography was performed to assess the situation.Finally, the wire and the balloon were completely removed by snaring.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date the incident occurred was estimate as (b)(6) 2019 which is the first day of the month of the aware date.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 108cm distal of the strain relief at the midshaft bond.There was contrast and blood in the inflation lumen and contrast in the balloon.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during inflation at 24 atmospheres, the shaft broke.Removal difficulty was noted so an optical coherence tomography was performed to assess the situation.Finally, the wire and the balloon were completely removed by snaring.No patient complications were reported.

• 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: 8960176
• Report Number: 2134265-2019-10622
• Device Sequence Number: 16858754
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0023584574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention