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

Model Number	7211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in mildly tortuous and moderately calcified mid left main and left anterior descending (lad) artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilatation, however, during the procedure the shaft kinked and when the device was removed, a fracture was noted 10cm into the balloon.Another nc emerge balloon was used.A 8 x 4.00 promus elite mr drug-eluting stent was then introduced, but it became stuck in the guide catheter.When the device was pulled back, the stent was noted to be frayed.All devices were removed from the body and the procedure completed with another of the same stent.There were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of an incomplete device return of an nc emerge mr balloon catheter.The device was microscopically and visually examined.A total length of 23.8cm was returned.There was shaft separation at the proximal end of the rapid port exchange which exposed the inflation lumen.There was blood and contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen.The balloon was loosely folded which is indicative of balloon inflation, however, given the exposed inflation lumen there was no detection of balloon damage.The incomplete device return was missing the manifold, strain relief, entire hypotube, and a portion of the inflation lumen.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in mildly tortuous and moderately calcified mid left main and left anterior descending (lad) artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilatation, however, during the procedure the shaft kinked and when the device was removed, a fracture was noted 10cm into the balloon.Another nc emerge balloon was used.A 8 x 4.00 promus elite mr drug-eluting stent was then introduced, but it became stuck in the guide catheter.When the device was pulled back, the stent was noted to be frayed.All devices were removed from the body and the procedure completed with another of the same stent.There were no patient complications.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14255062
• Report Number: 2134265-2022-05016
• Device Sequence Number: 17486820
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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: 01/05/2024
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0028627048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male