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

Model Number X

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2022

Event Type  Injury  

Event Description

It was reported the procedure was performed to treat the left anterior descending artery with moderate calcification and tortuosity.The pressurewire x, wireless device was advanced and resistance was met with the introducer sheath.The physician proceeded with advancement as the resistance ceased but was unable to make the turn out of the left main into the left anterior descending artery.The device was therefore removed and replaced.At the end of the procedure, the introducer sheath was flushed, and green material (assumed to be teflon) was noted to be coming out of the introducer sheath.It is unknown if the green material came off while the pressurewire x was in the anatomy.There was no clinically significant delay in the procedure.No additional information was provided.

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.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty/failure to advance was not tested as it was based on procedural circumstances.There was no peeling of the coating observed; however, the teflon was noted to be scraped in multiple locations.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 revealed no indication of a lot specific product quality issue.The investigation determined that the reported difficulty advancing, failure to cross and scraped teflon resulting in potential foreign body in patient was related to circumstances of the procedure.Based on the reported information resistance was met with the introducer sheath and continued attempt to advance against resistance was unsuccessful.It is likely that the introducer sheath was kinked or bent in the anatomy preventing advancement.Additionally, while attempting to advance against resistance, it likely that damage/scrapes to the pressurewire teflon coating occurred.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: 15114246
• MDR Text Key: 296702712
• Report Number: 2024168-2022-08229
• 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,Followup
• Report Date: 09/08/2022

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: 09/30/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 11028G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 82 KG