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

Model Number	1012276-15
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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.
Event or Problem Description
It was reported that the procedure was to treat the bifurcation of the circumflex and left anterior descending (lad) coronary arteries with a kissing balloon technique.The 3.5x15 mm trek balloon dilatation catheter (bdc) was inflated many times to nominal pressure and then completely failed to deflate.The balloon was withdrawn inflated.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported failure to deflate could not be replicated in a testing environment due to the condition of the returned device.Production record and corrective and preventative 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.It was reported that the balloon did not deflate resulting in the balloon being removed fully inflated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use ifu, states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is unlikely that the ifu violation contributed to the reported complaint, given the clinical situation.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported failure to deflate could not be determined.Possible factors that may contribute to failure to deflate include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen, contrast concentration or damage to the guide wire and/or inflation lumen.Return device analysis noted stretching at the inner and outer member (shaft) proximal from the balloon proximal seal.It was also reported that the device was successfully inflated many times to nominal pressure which indicates that it was likely deflated and possibly repositioned throughout the procedure.In this case, it is possible that the repositioning of the device may have resulted in the noted inner member and outer member (shaft) stretching at the proximal from the balloon proximal seal which subsequently contributed to the reported failure to deflate; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5 - describe event or problem: updated.H6: medical device problem code 2017: incorrect removal.
Event or Problem Description
Subsequent to the initially filed report, returned device analysis identified that the shaft was separated.The account was not aware; however, all devices in place were removed as a single unit.No additional information was provided.

• Brand Name: 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: 20621716
• Report Number: 2024168-2024-12989
• Device Sequence Number: 15679836
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)270430(10)40510G1
• 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): 12/09/2024

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: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 40510G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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