MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012455-12
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the ostial right coronary artery (rca).After post dilatation with the 5.0x12mm nc trek balloon dilatation catheter (bdc) at 18 atmospheres, it was noted that the balloon would not deflate after several times of holding negative for a few minutes.It was attempted to remove the bdc and was pulled to the aorta, but the balloon was too large to remove without damaging another artery.Therefore, bdc had to be over dilated and ruptured in order to remove and pull it our from the guiding catheter as it was noted the balloon would not fit into the guiding catheter when inflated.There was no adverse patient sequela and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat the ostial right coronary artery (rca).After post dilatation with the 5.0x12mm nc trek balloon dilatation catheter (bdc) at 18 atmospheres, it was noted that the balloon would not deflate after several times of holding negative for a few minutes.It was attempted to remove the bdc and was pulled to the aorta, but the balloon was too large to remove without damaging another artery.Therefore, bdc had to be over dilated and ruptured in order to remove and pull it our from the guiding catheter as it was noted the balloon would not fit into the guiding catheter when inflated.There was no adverse patient sequela and no clinically significant delay reported in the procedure.Subsequently, after the initial was filed it was noted that after the second inflation the balloon was slow to deflate; however, it did not fully deflate.Therefore, the device was inflated for a third time and it was noted to completely failed to deflate.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported deflation issue and failure to deflate could not be confirmed.The reported entrapment of device could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue and failure to deflate; however, the reported entrapment of device or device component and unexpected medical intervention appear to be related to circumstances of the procedure.Additional treatment was performed by over dilated and rupturing the device, in order to remove and pull it out from the guiding catheter.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: device code added 1149 deflation problem.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16303550
• Report Number: 2024168-2023-01204
• Device Sequence Number: 20374926
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 05/31/2025
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 20602G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• 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: 03/06/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown