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

Model Number	7214
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as the correct date was not provided.
Event or Problem Description
It was reported that catheter became stuck on the guidewire.The target lesion was located in the calcified in-stent restenosis left anterior descending artery.A 2.25mm x 20mm nc emerge balloon catheter was advanced and had two wires.However, the balloon got stuck on the wire and so the physician decided to pulled everything out from the patient's body.As soon as these devices were out, the balloon shaft broke upon separating it from the wire.Another 3.0mm x 20mm nc emerge balloon catheter was advanced along with one wire.The balloon does not slide over the wire and got stuck as well and so it was pulled out from the body.It was then noted that the lumen integrity was stretched.The procedure was completed with a non-bsc device.No patient injury nor adverse event were reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2020 as the correct date was not provided.Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The inflation lumen is separated 26cm from the tip.The inflation lumen is stretched at both ends of the separation.There is multiple buckling to the guidewire lumen and balloon.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter became stuck on the guidewire.The target lesion was located in the calcified in-stent restenosis left anterior descending artery.A 2.25mm x 20mm nc emerge balloon catheter was advanced and had two wires.However, the balloon got stuck on the wire and so the physician decided to pulled everything out from the patient's body.As soon as these devices were out, the balloon shaft broke upon separating it from the wire.Another 3.0mm x 20mm nc emerge balloon catheter was advanced along with one wire.The balloon does not slide over the wire and got stuck as well and so it was pulled out from the body.It was then noted that the lumen integrity was stretched.The procedure was completed with a non-bsc device.No patient injury nor adverse event 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: 9720510
• Report Number: 2134265-2020-01484
• Device Sequence Number: 18922861
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• 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): 03/19/2020

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: 11/10/2021
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0024745366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR