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

Model Number	1012403-08A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Subsequent to the initial report being filed it was reported that the mini trek ii bdc was a 2x8mm.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional, and scanning electron microscopy (sem) analysis was performed on the returned device.The reported leak was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The balloon was sent to the sem lab for further analysis.The sem report determined the device leakage from the proximal end of the luer may possibly be attributed to a gap/channel in the adhesive at the proximal bond area.Radial cross-sections were performed just distal to the bond area and just proximal to the glue port.Cross-section views revealed gaps/channels between the inner member and adhesive and the adhesive and inner surface of the luer lumen.The investigation determined the reported leak and noted gaps/channels between the inner member and adhesive, and the adhesive and inner surface of the luer lumen in the sidearm appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated d4: lot # updated from 40123g1 to 31219g1.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in a unspecified artery.The 2x6mm mini trek ii balloon dilatation catheter (bdc) was attempted to be used in the procedure; however, a leak was noted between the internal lumen and the balloon lumen.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.Another balloon was used to complete the procedure.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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19588227
• Report Number: 2024168-2024-07468
• Device Sequence Number: 7278981
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: (01)08717648180866(17)261130(10)31219G1
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 31219G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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