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

Model Number X

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2023

Event Type  Injury  

Event Description

It was reported that procedure was performed in the proximal circumflex into the left main coronary artery.During the procedure, the pressurewire tip had some resistance the with a previously implanted stent during advancement and during withdrawal, and the tip detached and remained in the anatomy.The patient was brought back on (b)(6) 2023.A snare was used in an attempt to retrieve the tip but was unsuccessful.A stent was implanted to secure the separated tip against the vessel wall.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 similar complaints reported from this lot.Based on the reported information, the reported difficulty advancing, difficulty removing and material separation resulting in unexpected medical intervention to embed the separated tip against the vessel wall appears to be related to circumstances of the procedure.It is likely that the reported resistance advancing, difficulty removing, and tip separation was due to interaction with the previously implanted stent.It is likely that the pressurewire tip became stuck with the implanted stent causing separation during removal.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: 17345566
• MDR Text Key: 319328977
• Report Number: 2024168-2023-07663
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2023

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 Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20721G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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): Disability; Required Intervention
• Patient Sex: Male