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

Model Number 1012454-12

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 04/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, 99% stenosed lesion in the right coronary artery (rca).A 4.5x12mm nc trek balloon dilatation catheter (bdc) was advanced to the lesion and inflated 3 times from 12 to 16 atmospheres (atm) and held for 10 seconds but could not be pulled back into the catheter to be removed from the anatomy.The patient¿s blood pressure (bp) and heart rate dropped, and all the devices were pulled out of the anatomy as a single unit with force.The patient was given medications to successfully treat the hypotension and bradycardia.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

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.The reported patient effect of hypotension is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) as a known patient effect.It was reported that force had to be applied to remove the bdc from the guiding catheter.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, ifu, states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, the ifu deviation did not contribute to the reported complaint.The investigation was unable to determine a conclusive cause for the reported difficulty removing the balloon dilatation catheter (bdc) from the guiding catheter; however, the reported required medication appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of bradycardia and hypotension and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: health effect - impact code 4641 - removed.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: 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: 14463210
• MDR Text Key: 292501423
• Report Number: 2024168-2022-05475
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 10921G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention