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

Model Number	1012454-08
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that during device preparation of the 4.50x8mm nc trek balloon dilatation catheter (bdc), there was no difficulty removing the protective sheath.The bdc was prepped (air aspiration) outside the patient anatomy and the contrast mix was 90 saline/10 contrast.The procedure was performed to treat a lesion in left anterior descending (lad) coronary artery with moderate calcification.The bdc was advanced to the target lesion and inflated; however, when attempting to deflate the balloon after the first inflation the balloon did not completely deflate; even though, the balloon was held at negative pressure for at least 15 seconds.In order to remove the partially deflated balloon, the bdc was yanked from the patient anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported deflation issue was unable to be confirmed as deflation times were measured 3 times and were within specifications 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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon was removed partially inflated.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, the ifu violation did not contributed to the reported difficulty and was necessary given the clinical situation.In addition, it was reported that the contrast mix used in the procedure was 90% saline/ 10% contrast.It should be noted that the ifu specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 15056414
• Report Number: 2024168-2022-07894
• Device Sequence Number: 4667496
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 1012454-08
• Device Catalogue Number: 1012454-08
• Device Lot Number: 20430G1
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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
• Patient Sex: Unknown