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

Model Number	7213
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first day of the month of (b)(6) since the only given date of event was (b)(6) 2020.
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that device entrapment and shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, the balloon was stuck on the wire and while attempting to pull it out of the body, the balloon was noted to have broken off the delivery system.No patient complications were reported.
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that device entrapment and shaft break occurred.The target lesion was located in the left anterior descending (lad) artery.A 3.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, the balloon was stuck on the wire and while attempting to pull it out of the body, the balloon was noted to have broken off the delivery system.No patient complications were reported.It was further reported that the mid lad contained 95% stenosis and 75% in-stent restenosis in distal lad.During removal, femoral access was gained and a 6fr jr4 caheter and a gooseneck catheter were used to successfully remove the balloon tip.

• 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: 10594170
• Report Number: 2134265-2020-12836
• Device Sequence Number: 1151981
• Product Code: LOX
• UDI-Device Identifier: 08714729846550
• UDI-Public: 08714729846550
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 02/06/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025173004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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
• Patient Age: 58 YR