MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MINI TREK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012403-08A
Medical Device Problem Codes	Inflation Problem (1310); Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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.Medical device problem code: 1494 incorrect anatomy.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the vein of marshall.A 2.0x8mm mini trek balloon dilatation catheter (bdc) was advanced to the lesion and attempted to be inflated; however the balloon was noted to be ruptured during its first inflation to 8atm.The mini trek bdc was replaced with another bdc and the procedure was completed.There were no reported adverse patient effects nor clinical delay.No additional information has been provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, and scanning electron microscopy analysis were performed on the returned device.The reported inflation issue was confirmed.The production record review was performed and revealed no indication of a product quality issue.The corrective and preventive actions (capa) review was performed and revealed capa issues related to the reported issue; indicating there is a potential product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported that the procedure was to treat a lesion in the vein of marshall.It should be noted that the coronary dilatation catheters (cdc), mini trek ii over the wire (otw), global, information for use (ifu), indications for use section) states: 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 a potential product quality issue based on the evaluation of the returned device and the review of the corrective and preventive actions (capa) database.A leak was observed at the proximal end of the hub guidewire port.It was determined the luer leak may be attributed to an inner member materials/processing discrepancy and/or exposure conditions.Additionally, it is likely that the noted leak at the hub resulted in the reported inflation issue and the perception of a balloon rupture, since the balloon would not hold pressure.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6 medical device problem code correction: code 1546 was removed and code 1310 added.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the vein of marshall.A 2.0x8mm mini trek balloon dilatation catheter (bdc) was advanced to the lesion and attempted to be inflated; however the balloon was noted to be ruptured during its first inflation to 8atm.The mini trek bdc was replaced with another bdc and the procedure was completed.There were no reported adverse patient effects nor clinical delay.Subsequent to the initially filed report, the device was received and the qat analysis could not confirm the balloon rupture; however, noted a leak in the hub.The account confirmed that no rupture was noted on the balloon, and instead they were reporting that the bdc was unable to be inflated.No additional information was provided.

• Brand Name: MINI TREK¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20939804
• Report Number: 2024168-2024-14749
• Device Sequence Number: 14594077
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: (01)08717648180866(17)270930(10)41030G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123279
• 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): 04/01/2025

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 Model Number: 1012403-08A
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 41030G1
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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