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

Model Number	1012403-06A
Medical Device Problem Codes	Inflation Problem (1310); Off-Label Use (1494); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the coronary sinus vein.A 2x6mm mini trek ii over the wire (otw) balloon dilatation catheter (bdc) was difficult to inflate and the balloon ruptured during inflation.There was no adverse patient effect and no clinically significant delay in the procedure.Another balloon was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem codes 2017, 1494: incorrect prep, incorrect anatomy.Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported rupture and inflation issue were confirmed.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 physicians do not activate the coating in a heparinized saline solution and the physicians inflate the balloon to test it before using it, to make sure it¿s fully functional before using it on a patient.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, per the ifu, states: 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.The ifu violations resulted in the reported balloon rupture.Furthermore, the account reported that the procedure was to treat a lesion in the coronary sinus vein.Per the ifu, the mini trek ii otw coronary dilatation catheter is 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 (mi), balloon dilatation of a stent after implantation (balloon models 2.00 mm only), balloon dilatation of de novo chronic total coronary occlusions (cto).In this case, it is unknown if the ifu violation contributed to the reported complaint because abbott has not evaluated this use.The investigation determined the reported balloon rupture is related to user error; however, the reported inflation difficulty appears to be related to operational context.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: 16162234
• Report Number: 2024168-2023-00482
• Device Sequence Number: 20572538
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/03/2023
• 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