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

Model Number	6533
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 that the hypotube is separated 59.4cm from the hub and appears to have been kinked prior to separation.There are multiple kinks along the hypotube.Microscopic examination revealed that the tip is damaged.There is blood present in the inflation lumen and balloon.The balloon was still tightly folded prior to inflation testing.The presence of dried blood in the inflation lumen made it unable to be inflated so the device was soaked in a water bath for a few days to soften the blood.A touhy adaptor was connected to the separated hypotube and the balloon was inflated to rated burst pressure (rbp).It could hold pressure for 5 minutes.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that balloon inflation failure occurred.Vascular access was obtained via the femoral artery.The concentric target lesion was located in the mildly calcified mid right coronary artery.The lesion contained >=90 degrees bend.A 20mm x 2.75mm nc quantum apex balloon catheter was advanced for dilatation, but the balloon failed to inflate.The procedure was completed using another balloon with buddy wire support.There were no patient complications reported and the patient was stable and doing well.However, returned device analysis revealed a separated hypotube.

• 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: 8674131
• Report Number: 2134265-2019-06231
• Device Sequence Number: 2359543
• Product Code: LOX
• UDI-Device Identifier: 08714729783473
• UDI-Public: 08714729783473
• 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
• Report Date (Section B): 06/06/2019

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: 08/18/2020
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0021030036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 51