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

Model Number X

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

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 an unknown vessel.The pressurewire x, wireless device was inserted.However, it was observed the device was peeling.Therefore, the device was removed and replaced.There were no adverse patient effects and no clinically significant delay in the procedure.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 revealed no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported peeling.It may be possible that the coating was damaged or peeled off during insertion through the guidewire introducer needle or associated devices; however, without having the device to examine, 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.D9, h3: device return status updated from yes to no.

• 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: 14164241
• MDR Text Key: 289735762
• Report Number: 2024168-2022-04282
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20125G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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