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

Model Number	7211
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was fibrotic plaque within the left anterior descending artery.A 4.00mm x 15mm nc emerge balloon catheter was advanced for post dilation.However, the balloon got stuck onto the wire and was not able to be removed without pulling out both devices together.After that, a new 4.00mm x 8mm nc emerge balloon catheter and a non-bsc guidewire was placed, but after one inflation both devices got stuck also.And so both devices were removed.The procedure was completed with a placement of a new non-bsc wire into the vessel and ivus confirmed that the stent was well apposed.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
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 contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for one day to loosen the blood and contrast in the device.The device was functionally tested with a.014 inch guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was fibrotic plaque within the left anterior descending artery.A 4.00mm x 15mm nc emerge balloon catheter was advanced for post dilation.However, the balloon got stuck onto the wire and was not able to be removed without pulling out both devices together.After that, a new 4.00mm x 8mm nc emerge balloon catheter and a non-bsc guidewire was placed, but after one inflation both devices got stuck also.And so both devices were removed.The procedure was completed with a placement of a new non-bsc wire into the vessel and ivus confirmed that the stent was well apposed.No patient complications were 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: 9733595
• Report Number: 2134265-2020-01754
• Device Sequence Number: 2353048
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 12/04/2021
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0024877247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1