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

Model Number 1012455-15

Device Problems Deflation Problem (1149); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2021

Event Type  malfunction  

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 the device was used to treat a renal artery.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).Iit s unknown if the ifu deviation caused or contributed to the reported deflation issue.Additionally, the balloon was overinflated to 20 atmospheres (atms).The ifu states the balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.It is unknown if the reported ifu violation caused or contributed to the reported deflation issue.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.Na.

Event Description

It was reported the 5.0 x 15 mm nc trek balloon dilatation catheter (bdc) was advanced to treat in-stent restenosis in the renal artery.The balloon was inflated, twice, once to 20 atmospheres for 58 seconds and the second time to 8 atmospheres for 17 seconds.During deflation, the balloon did not fully deflate.Negative was held for a minute or more, multiple times.The balloon was removed without issue, with the balloon partially inflated.The procedure was complete at this time, no additional device was needed.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 11182401
• MDR Text Key: 227572210
• Report Number: 2024168-2021-00500
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 00706G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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