MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Catalog Number	1012403-08A
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the marshall vein.During injection of liquid in the 2.0x8 mm mini trek balloon dilatation catheter, there was a leak noted from a hole located at the connection/hub area of the device.This was preventing balloon inflation.Another unspecified balloon was used to complete the procedure.There were no adverse patient effects and there was a delay in the procedure; however, there was no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
H6: medical device problem code 1494 - incorrect anatomy.Visual, functional and scanning electron microscopy inspections/analysis were performed on the returned device.The reported inflation issue and leak 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 identified no other similar incidents and/or complaints from this lot.It was reported that the procedure was to treat the marshall vein.It should be noted that the coronary dilatation catheters (cdc), mini trek ii over the wire (otw), global, information for use (ifu) 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.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• 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: 17839797
• Report Number: 2024168-2023-10679
• Device Sequence Number: 12614770
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: 08717648180866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110617
• 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): 12/01/2023

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: 03/31/2026
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 30421G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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