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

Model Number	1012447-08
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 90% stenosed lesion in the proximal left circumflex (plcx) artery.A 2.0x15mm mini trek balloon dilatation catheter (bdc) was advanced for pre-dilatation, however, it could not be fully inflated due to the calcification in the lesion.A 2.5x8mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation and inflated to 20 atmospheres (atm) when the balloon ruptured.Intravascular ultrasound (ivus) showed a hematoma from the lcx to the left main (lm) coronary artery.A 2.75x15mm xience alpine drug eluting stent (des) was immediately implanted into the lcx ostium to prevent further tearing of the hematoma.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.It was reported that the balloon was inflated to 20 atmospheres.It should be noted that the coronary dilatation catheter (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.The investigation determined the reported balloon rupture and unexpected medical intervention appear to be related to operational context.Additionally, a conclusive cause for the reported patient effect of hematoma and the relationship to the product, if any, cannot be determined.The reported patient effect of hematoma is listed in the coronary dilatation catheter (cdc), nc trek rx, global, instruction for use (ifu) as a known patient effect.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6- device code 2017 clarifier: above rbpna.

• 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: 16869292
• Report Number: 2024168-2023-04716
• Device Sequence Number: 14962634
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/04/2023

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: 02/29/2024
• Device Model Number: 1012447-08
• Device Catalogue Number: 1012447-08
• Device Lot Number: 10304G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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