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

Model Number	6531
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 12mmx2.25mm nc quantum apex balloon catheter was used for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of an nc quantum apex 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.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a pinhole at the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 12mmx2.25mm nc quantum apex balloon catheter was used for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.It was further reported that the the device was completely removed from the patient's body through guide catheter.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 12mmx2.25mm nc quantum apex balloon catheter was used for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.It was further reported that the the device was completely removed from the patient's body through guide catheter.
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.

• 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: 9008575
• Report Number: 2134265-2019-11100
• Device Sequence Number: 16738571
• Product Code: LOX
• UDI-Device Identifier: 08714729783237
• UDI-Public: 08714729783237
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2019

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 Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0023077516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 10/14/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/01/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1