MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER

Model Number X

Device Problems Use of Device Problem (1670); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Vascular Dissection (3160)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that when advancing the pressurewire x (pwx) to the left circumflex artery, resistance was felt with the anatomy.The pwx crossed the lesion but the proximal part of the wire got twisted and a dissection occurred.The dissection was treated with a stent.The physician said the device has poor maneuverability.No additional information was provided.

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 of the reported lot did not indicate a lot specific quality issue.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.It was reported by the account that the pressurewire interacted with the patient anatomy resulting in the reported difficulty advancing the device/ease of handling and upon further manipulation, against resistance, port of the wire became twisted.The patient experienced a dissection, but it is unknown if the pressurewire contributed to it or if it was due to the morphology of the lesion.Additional treatment with a stent was performed to treat the dissection.The reported patient effect of dissection is listed in the pressurewire instruction for use (adverse events section) as a known potential complication which may be encountered during all catheterization procedures.In this case, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The investigation determined the difficulty advancing the device, use of device problem, material twisted/bent and unexpected medical intervention appear to be related to circumstances of the procedure.A definitive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Type of Device: CATHETER TIP PRESSURE TRANSDUCER
• 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: 16707460
• MDR Text Key: 312958435
• Report Number: 2024168-2023-03626
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20328G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic