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

Model Number	1012454-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery (rca).The 4.5x15 mm trek balloon dilatation catheter (bdc) was inflated once to 20 atmospheres (atm) for post dilatation and then it could not deflate and only partially deflated.Negative was held many times and the contrast mix was 3:1.Multiple syringes were exchanged and manual deflation would not work.Ultimately the device was deliberately broken in the aorta to be able to re-introduce it into the catheter to be removed.There were no reported patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery (rca).The 4.5x15 mm trek balloon dilatation catheter (bdc) was inflated once to 20 atmospheres (atm) for post dilatation and then it could not deflate and only partially deflated.Negative was held many times and the contrast mix was 3:1.Multiple syringes were exchanged and manual deflation would not work.Ultimately the device was deliberately broken in the aorta to be able to re-introduce it into the catheter to be removed.There were no reported patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was difficulty removing the device from the guiding catheter.The contrast ratio was 3 contrast:1 saline.The balloon was intentionally ruptured in the aorta in order to introduce it again with the guide wire and then remove it from the anatomy.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - above rated burst pressure.A visual and scanning electron microscopy (sem) inspection/analysis were performed on the returned device.The reported deflation issue and difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified one 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 nc trek balloon dilatation catheter (bdc) was inflated above the rated burst pressure (rbp), to 20 atmospheres (atm).It should be noted that the coronary dilatation catheters (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 rx device is 18 atm.Additionally, it was reported that the contrast ration used in the procedure was 3 contrasts:1 saline.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, since a potential product quality issue was identified, a conclusive contribution of the ifu violation could not be determined.The investigation determined the noted stretched shaft at the mid lap seal and reported deflation issue appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The reported difficulty removing the device from the guiding catheter and unexpected medical intervention appear to be related to circumstances of the procedure.

• 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: 14113053
• Report Number: 2024168-2022-04053
• Device Sequence Number: 16674694
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 01/31/2023
• Device Model Number: 1012454-15
• Device Catalogue Number: 1012454-15
• Device Lot Number: 00202G1
• 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: 06/06/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2020
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 90 KG