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

Model Number	7211
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that incorrect size of device occurred.The target lesion was located in the left anterior descending artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.However, it was noticed by the physician that the overhang on the balloon was more than he would have expected for an 8mm stent.It looked like it was 10-12mm.Nevertheless, the balloon worked fine and the procedure was completed.No patient complications were reported.
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.Microscopic inspection revealed tip damage.The marker bands measured 8mm from distal end to proximal end.There was no damage or deformities to the balloon, the marker bands, or inner shaft in the balloon.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that incorrect size of device occurred.The target lesion was located in the left anterior descending artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.However, it was noticed by the physician that the overhang on the balloon was more than he would have expected for an 8mm stent.It looked like it was 10-12mm.Nevertheless, the balloon worked fine and the procedure was completed.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: 9866353
• Report Number: 2134265-2020-03388
• Device Sequence Number: 13570286
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/16/2020

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: 12/18/2021
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0024956439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1