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	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used (b)(6) 2019, the first day of the month of the aware date as no exact date provided.
Event or Problem Description
It was reported that balloon puncture occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was opened for coronary angioplasty.During the pressure-negative prepping procedure with a syringe gauge, air was coming into the syringe and a balloon puncture was noted.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event - updated from (b)(6) 2019.
Event or Problem Description
It was reported that balloon puncture occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was opened for coronary angioplasty.During the pressure-negative prepping procedure with a syringe gauge, air was coming into the syringe and a balloon puncture was noted.No patient complications were reported.It was further reported at the time when aspiration was performed to make the negative pressure, it was noted that there was blood in the syringe.The procedure was completed with another of the same device.One to two days post procedure, the patient was discharged from the hospital.
Additional Manufacturer Narrative
B3: date of event - updated from 01aug2019 to 28aug2019 device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.Microscopic examination revealed a pinhole over the proximal markerband.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.
Event or Problem Description
It was reported that balloon puncture occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was opened for coronary angioplasty.During the pressure-negative prepping procedure with a syringe gauge, air was coming into the syringe and a balloon puncture was noted.No patient complications were reported.It was further reported at the time when aspiration was performed to make the negative pressure, it was noted that there was blood in the syringe.The procedure was completed with another of the same device.One to two days post procedure, the patient was discharged from the hospital.

• 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: 9090356
• Report Number: 2134265-2019-11068
• Device Sequence Number: 2297918
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/13/2020

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: 10/21/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022825376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 01/30/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/19/2019; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1