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

Model Number	6532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that shaft break occurred.The 97% stenosed target lesion was located in the severely tortuous, and moderately calcified left main coronary artery to left anterior descending artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pos-dilatation.However, during inflation, the shaft was broken.The device was pulled out.And completely removed from the patient's body.Another balloon was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 97% stenosed target lesion was located in the severely tortuous and moderately calcified left main coronary artery to left anterior descending artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for pos-dilatation.However, during inflation, the shaft was broken.The device was pulled out and completely removed from the patient's body.Another balloon was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 56cm from the strain relief.The separated ends were jagged and ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube and shaft of the device.There was contrast in the inflation lumen and blood within the balloon folds.The balloon was tightly folded.Product analysis confirmed the reported break as there was separation to the device.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17028227
• Report Number: 2124215-2023-25822
• Device Sequence Number: 17757197
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 09/22/2025
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0030203561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown