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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge balloon and a 15mm x 2.75mm nc quantum apex balloon were selected for use.During the procedure, the emerge balloon was inserted, followed by a non bsc stent and then post-dilated with an nc quantum balloon.However, it was noted that both emerge and nc quantum balloons ruptured.The procedure was successfully completed and the patient has recovered fully.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge balloon and a 15mm x 2.75mm nc quantum apex balloon were selected for use.During the procedure, the emerge balloon was inserted, followed by a non bsc stent and then post-dilated with an nc quantum balloon.However, it was noted that both emerge and nc quantum balloons ruptured.The procedure was successfully completed and the patient has recovered fully.Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed a pinhole in the balloon approximately 9mm from the tip.There is blood present in the guidewire lumen, inflation lumen, and balloon.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.No other issue reported.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 04:02 pm ct.The report number is being corrected from: 2134265-2018-64379 to: 2134265-2018-63201.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8112400
• Report Number: 2134265-2018-63201
• Device Sequence Number: 2165779
• Product Code: LOX
• UDI-Device Identifier: 08714729783367
• UDI-Public: 08714729783367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: 09/30/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022727620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: 2.50MM X 12MM EMERGE; BALLOON CATHETER: 2.50MM X 12MM EMERGE; INFLATION DEVICE: ENCORE; INFLATION DEVICE: ENCORE; STENT: XIENCE; STENT: XIENCE; BALLOON CATHETER: 2.50MM X 12MM EMERGE; INFLATION DEVICE: ENCORE; STENT: XIENCE