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 Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a shaft break occurred, followed by a dissection and hematoma, requiring additional intervention.A nc quantum apex balloon and a synergy ii des stent balloon were selected for use in a percutaneous coronary intervention (pci) procedure.The balloon fractured and had to be retrieved.The intact, fractured balloon was trapped inside the guide catheter using the guidewire and the entire system was removed.Ivus showed a dissection and hematoma.The cause for the reported dissection and hematoma remains unknown.Additional stenting was performed to resolve the injuries.The patient was fully recovered.
Event or Problem Description
It was reported a shaft break occurred, followed by a dissection and hematoma, requiring additional intervention.A nc quantum apex balloon and a synergy ii des stent balloon were selected for use in a percutaneous coronary intervention (pci) procedure.The balloon fractured and had to be retrieved.The intact, fractured balloon was trapped inside the guide catheter using the guidewire and the entire system was removed.Ivus showed a dissection and hematoma.The cause for the reported dissection and hematoma remains unknown.Additional stenting was performed to resolve the injuries.The patient was fully recovered.Additional information: it was further reported that the severely calcified, moderately tortuous, 80% stenosed bifurcation lesion was located in the ostial diagonal and evolved to the left anterior descending artery (lad).Additionally, there was a previously implanted under-expanded stent.The patient was presenting with chest pain, believed to be caused by the under-expanded stents.Intravascular ultrasound(ivus) confirmed a gap at the ostial diagonal, and this was the target region to stent.However, the stent could not be delivered.The lad stent was ballooned further, but could still not be delivered.The kissing technique was attempted using two 3.0mm x 12mm nc quantum devices.The first nc quantum apex was placed in the diagonal ostium, and when trying to place the second nc quantum apex in the lad, the device jammed at the tip of the guide catheter and could not be moved forward or backward.The balloons were pulled out together, and the first nc quantum balloon fractured.The second nc quantum balloon was removed intact.The stiff section of the fractured balloon was removed, however, the soft remaining section of the nc quantum device system moved back (during pulling) from the ostial diagonal to just beyond the tip of the guide catheter and remained on the diagonal wire.The fractured nc quantum section was retrieved by another semi-complaint balloon 2.0 x 8 which was inflated on the lad wire at low pressure beyond the detached portion.The noted dissection occurred in the proximal lad prior to the existing stent, which was diseased and planned to be stented.The cause of the dissection is unknown, but according to the physician predilation by the 3.0 x 12 nc quantum or the act of pulling the inflated balloon for the retrieval of the fractured device could have expanded the existing dissection.The dissection was covered by a stent.It was additionally noted that the synergy stent fractured outside the guide catheter and outside of the body.However, the timeline of when this fracture occurred in regards to the procedure is not known.

• 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: 17477075
• Report Number: 2124215-2023-41938
• Device Sequence Number: 11447134
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0031062552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown