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

Model Number	6531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation of the deployed 2.75x18mm non-bsc stent at 20 atmospheres for 14 seconds, the balloon ruptured.When the physician tried to retrieve the balloon, the proximal 37cm of the balloon had separated from the balloon shaft.The separated proximal 37cm of the balloon catheter was retrieved from the patient's body and at close inspection, it appeared that the balloon did not burst.The failure was at the connection where the proximal 37cm meets the rest of the balloon shaft.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.50mm nc quantum apex balloon catheter was advanced for post dilatation.However, during inflation of the deployed 2.75 x 18mm non-bsc stent at 20 atmospheres for 14 seconds, the balloon ruptured.When the physician tried to retrieve the balloon, the proximal 37cm of the balloon had separated from the balloon shaft.The separated proximal 37cm of the balloon catheter was retrieved from the patient's body and at close inspection, it appeared that the balloon did not burst.The failure was at the connection where the proximal 37cm meets the rest of the balloon shaft.No patient complications were reported.
Additional Manufacturer Narrative
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 hypotube kinks.There was blood and contrast in the inflation lumen and contrast in the balloon.There was blood in the guidewire lumen.The balloon was loosely folded.There was a complete separation at the midshaft weld.There was 4mm of adhesive present on the midshaft weld, which is passing per specifications.Inspection of the remainder of the device presented no other damage or irregularities.Correction to field: report source.

• 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: 8586992
• Report Number: 2134265-2019-04739
• Device Sequence Number: 1666887
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 01/16/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0023202442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1