MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-30
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left tibial artery.Two 4x30mm trek balloons were used in the same procedure.Both were inflated twice at 12 atmospheres without issues.However, the first trek balloon during removal resistance was met when the balloon separated and was the successfully snared out.For the second trek balloon, during removal resistance was met when the balloon separated and was left in the body and crushed against the artery with a stent.Resistance during removal for both balloons was met with an unspecified source.Another non-abbott balloon was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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.The additional trek device referenced is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Device code 1494: incorrect anatomy.Device code 2017: incorrect prep.Visual inspection was performed on the returned device.The reported balloon separation was not confirmed; however, it is likely that the separation noted at the guide wire exit notch is what the account perceived as the reported separation.The reported difficulty removing the device could not be replicated in a testing environment due to the device condition.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 that the bdc was not soaked before use.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek, global, information for use (ifu) states: note: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.In this case, it is unknown if the ifu violation contributed to the reported compliant; therefore, an in-service will not be requested for the account.Additionally, it was reported that the procedure was to treat a left tibial artery.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the ifu violation contributed to the reported compliant.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation, additional treatment and device embedded in tissue or plaque appears to be related to circumstance of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was to treat a left tibial artery.Two 4x30mm trek balloons were used in the same procedure.Both were inflated twice at 12 atmospheres without issues.However, the first trek balloon during removal resistance was met when the balloon separated and was the successfully snared out.For the second trek balloon, during removal resistance was met when the balloon separated and was left in the body and crushed against the artery with a stent.Resistance during removal for both balloons was met with an unspecified source.Another non-abbott balloon was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.Per re-evaluation of the event, the account confirmed that the balloons were not soaked prior to use.Additionally, each balloon was used independent of the other.No additional information was provided.

• Brand Name: 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: 13044454
• Report Number: 2024168-2021-11891
• Device Sequence Number: 12124951
• Product Code: LOX
• UDI-Device Identifier: 08717648138744
• UDI-Public: 08717648138744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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): 01/27/2022

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: 09/30/2023
• Device Model Number: 1012278-30
• Device Catalogue Number: 1012278-30
• Device Lot Number: 01001G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: 80 YR
• Patient Sex: Female