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

Model Number	6531
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified distal right coronary artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, upon insertion, a slight resistance was felt, and when minimal force was applied, the proximal shaft was completely fractured at approximately 15cm from the hub.The device was retrieved from the patient without any complications and physician decided to just refer for the consultation instead of attempting another balloon insertion.
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 14.8 cm from the strain relief.There were numerous kinks to the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon was tightly folded.At 3mm distal to the bicomponent weld, for a length of 1mm, the guidewire lumen was buckled.Product analysis confirmed the reported break as there was separation to the device.Product analysis could not confirm the reported difficulty to advance, as the clinical circumstances could not be replicated; however, the guidewire lumen was buckled and there were numerous kinks to the hypotube and shaft of the device.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified distal right coronary artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, upon insertion, a slight resistance was felt, and when minimal force was applied, the proximal shaft was completely fractured at approximately 15cm from the hub.The device was retrieved from the patient without any complications and physician decided to just refer for the consultation instead of attempting another balloon insertion.

• 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: 17198010
• Report Number: 2124215-2023-32921
• Device Sequence Number: 12183417
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 03/15/2026
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0031243604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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