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

Model Number X

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was performed in the proximal left anterior descending artery.The pressurewire x, wireless (pwx) device was inserted, and fractional flow reserve (ffr) was successfully performed.The pwx was removed, and a stent was implanted.The pwx was reinserted for post assessment, but during advancement, the tip of the pwx became caught on the implanted stent and separated.Therefore, the pressurewire was removed, and a snare was inserted.However, the tip of the pwx was unable to be retrieved, so the physician decided to implant another stent over the first stent to trap the wire tip.An optical coherence tomography (oct) run was performed, and it was confirmed the tip of the wire was between the two implanted stents.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.Additionally, a review of the provided still image and oct video were reviewed by an abbott clinical research & development advisor.The still frame angiography image shows a radiolucent tip of the pressurewire x wire in the lad.The attached oct video did not correlate with corresponding angiography image.A device malfunction was confirmed via the still frame image provided.A probable cause of the malfunction could not be determined from the images provided.The reported difficulty to remove was not able to be confirmed with the returned device as it was based on circumstances of the procedure.The reported separation was confirmed on the returned device.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported difficulty advancing and subsequent separation resulting in unexpected medical intervention to embed the separated portion of the pressurewire tip.It may be possible that during advancement of the pressurewire for post assessment, the tip of the wire became caught within the newly implanted stent (possibly within the stent struts) resulting in separation.However, this could not be confirmed.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: 14380863
• MDR Text Key: 291970380
• Report Number: 2024168-2022-05201
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 11104G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: IMPLANTED STENT.
• Patient Outcome(s): Required Intervention