MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-25
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Above rated burst pressure.The device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, 50-70% stenosed lesion in the left anterior descending (lad) artery.A 3x25mm trek balloon dilatation catheter (bdc) was advanced to the target lesion for pre-dilatation and inflated one time to 20 atmospheres (atm) when the balloon ruptured.Some of the balloon pieces were snared from the anatomy and other pieces could not be snared and were stented in place in the anatomy.After the procedure the patient seemed fine and was discharged from the hospital that same day.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 balloon dilatation catheter (bdc) was overinflated to 20 atmospheres (atms) and the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), trek rx global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.In this case, it is likely the ifu deviation resulted in the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to user error; however, the reported unexpected medical intervention, device embedded in tissue or plaque and removal of foreign body appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK 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: 15255484
• Report Number: 2024168-2022-08921
• Device Sequence Number: 6672246
• Product Code: LOX
• UDI-Device Identifier: 08717648138454
• UDI-Public: 08717648138454
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012274-25
• Device Catalogue Number: 1012274-25
• Device Lot Number: 00429G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Weight: 112 KG