MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER

Model Number	1012403-06A
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Device code 2017 incorrect prep.The additional vascular device are filed under separate medwatch report number.
Event or Problem Description
It was reported that during device preparation of two 2.00x6mm mini trek balloon dilatation catheters (bdc), the devices were not soaked in a saline solution.Additionally, the balloons were inflated outside the anatomy to less than 4 atmospheres, to ensure functionality prior to use.Both balloons ruptured.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The balloon rupture was confirmed.It was noted that fluid came out of a flap in the balloon distal to the proximal balloon marker, confirming the reported complaint.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 balloon was not soaked and was inflated to test it before using it.It should be noted that the coronary dilatation catheters (cdc), mini trek ii over the wire (otw), global, information for use (ifu) states: note: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.If the coating is not properly activated or hydrated, it keeps the balloon pleats affixed or stuck with each other, potentially causing balloon damage as the balloon expands from its compressed state to being fully inflated, causing irregular ruptures/tears or delamination within the surface of the balloon during inflation.Additionally, remove all air from the syringe or inflation device barrel.Reconnect the syringe or inflation device to the inflation port of the dilatation catheter.Maintain negative pressure on the balloon until air no longer returns to the device.Slowly release the device pressure to neutral.Based on the returned device analysis, it has been determined that insufficient prep and inflating the balloon outside of the patient anatomy while being insufficiently prepped, led to the noted flap rupture.The ifu violations resulted in the reported balloon rupture.The investigation determined the reported balloon rupture is related to user error.Based on the returned device analysis, it has been determined that insufficient prep and inflating the balloon outside of the patient anatomy while being insufficiently prepped, led to the noted flap rupture.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI TREK II OTW 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: 16547206
• Report Number: 2024168-2023-02695
• Device Sequence Number: 6042559
• Product Code: LOX
• UDI-Device Identifier: 08717648180859
• UDI-Public: 08717648180859
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 09/30/2025
• Device Model Number: 1012403-06A
• Device Catalogue Number: 1012403-06A
• Device Lot Number: 21020G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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