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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of a nc emerge balloon catheter.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded and contained contrast.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 18.8cm distal of the strain relief.The hypotube fracture surfaces were oval, which suggests the device was kinked prior to separation.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered, unintended use error caused or contributed to event, due to the kinks and separation were from the user handling the device.This complaint investigation conclusion code is utilized for the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.
Event or Problem Description
It was reported that shaft break occurred.The 3.9mm x 2 target lesion was located in the non tortuous mildly calcified left anterior descending artery (lad).A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, upon insertion, the shaft broke at the rapid exchange port.The device was removed and replaced with another balloon and completed the procedure successfully.No patient complications nor injuries 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: 8570679
• Report Number: 2134265-2019-04705
• Device Sequence Number: 2346408
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 05/01/2019

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: 02/24/2021
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0023394181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1