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

Model Number	6531
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the non-tortuous and severely calcified left main artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured and completely came off the shaft.A snare was used to try and retrieve the balloon fragment but was unsuccessful.Subsequently, the balloon fragment was stented in the left main artery.There were no patient complications reported and the patient has fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an incomplete device return of an nc quantum apex balloon catheter along with unknown tiny fragment sections.The device was visually and microscopically examined.There were numerous bends and kinks to both the shaft and the hypotube.There was contrast and blood in the inflation lumen.At 20cm from the rpe (rapid port exchange), the guidewire lumen was buckled for a length of 1mm.At 21.3cm from the rpe, there was a separation of the inflation lumen.The shaft edges of the separation are indicative of a burst as the shaft was stretched and blown apart.At 26cm from the rpe, there was separation of the guidewire lumen.The guidewire lumen was stretched down for a length of 2mm at the separation point.The total returned length of the device was 144.1cm from the strain relief.The device was returned incomplete as the distal portion of both the inflation lumen and guidewire lumen, the balloon, markerbands and tip of the device were not returned.Tiny fragment sections were returned.One section was 7mm in length and the other was 3mm.Ftir testing was performed on the returned fragments.Analysis indicates the fragments are most likely to be fibrous and of nylon material.Product analysis was able to confirm the reported events as the shaft separation of the device confirms the reported material rupture and detachment.
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the non-tortuous and severely calcified left main artery.A 12mm x 3.50mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured and completely came off the shaft.A snare was used to try and retrieve the balloon fragment but was unsuccessful.Subsequently, the balloon fragment was stented in the left main artery.There were no patient complications reported and the patient has fully recovered.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13971670
• Report Number: 2134265-2022-03737
• Device Sequence Number: 6626832
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 10/03/2024
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0028133044
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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