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

Model Number	6530
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified left anterior descending (lad) artery and left circumflex (lcx) artery.A 2.00x12 maverick balloon was advanced for dilatation but failed to cross the lesion and was replaced with a non-boston scientific (bsc) balloon.Following pre-dilatation, a 3.00x16 and 2.50x24 synergy drug-eluting stents were advanced into the lad and lcx respectively but failed to cross.Both stents were removed and replaced with two non-bsc stents.A 2.75x8 nc quantum apex balloon was used to optimize the proximal portion of lcx stent, while a 3.50x8 nc quantum apex balloon was advanced but failed to cross and got stuck in the proximal portion of the lad stent and was removed with some difficulty.Another 3.50x8 nc quantum apex balloon was used to complete the proximal optimization technique successfully.The procedure was completed with no patient complications.
Additional Manufacturer Narrative
Returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There was a kink to the hypotube 2cm distal to the strain relief.There was contrast in the inflation lumen and the balloon.The shaft was twisted for a length of 2mm at the proximal end of the rapid port exchange (rpe).The balloon was loosely folded, and the tip was damaged.Product analysis could not confirm the reported event, as the clinical circumstances could not be replicated.There was tip damage, and the shaft was twisted.There was also a hypotube kink found to the device.
Event or Problem Description
It was reported that removal difficulty was encountered.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified left anterior descending (lad) artery and left circumflex (lcx) artery.A 2.00x12 maverick balloon was advanced for dilatation but failed to cross the lesion and was replaced with a non-boston scientific (bsc) balloon.Following pre-dilatation, a 3.00x16 and 2.50x24 synergy drug-eluting stents were advanced into the lad and lcx respectively but failed to cross.Both stents were removed and replaced with two non-bsc stents.A 2.75x8 nc quantum apex balloon was used to optimize the proximal portion of lcx stent, while a 3.50x8 nc quantum apex balloon was advanced but failed to cross and got stuck in the proximal portion of the lad stent and was removed with some difficulty.Another 3.50x8 nc quantum apex balloon was used to complete the proximal optimization technique successfully.The procedure was completed with no patient complications.

• 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: 16274248
• Report Number: 2124215-2023-03555
• Device Sequence Number: 20331388
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: 08714729783176
• 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): 07/05/2023

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: 06/14/2025
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0029591626
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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: Male