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

Model Number X

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was performed in the mildly tortuous and mildly calcified lesion in the right coronary artery.The pressurewire x was difficult to remove from the patient.It was noted that the wire split near the radiopaque segment.After several attempts to twist and pull, the device finally became free and was able to be removed.The procedure was successfully completed with a new pressurewire x.There were no adverse patient effects and 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 to remove was not co nfirmed as it was based on procedural circumstances.Furthermore, the reported material splitwas not confirmed during visual analysis.Visual analysis noted that the distal tip core was bent 4mm proximal to the distal end.The distal tip coils were stretched distal to the sensor jacket for a length of 3mm.The distal tube was kinked 8mm proximal to the sensor jacket.The micro cables were bent at the noted kinked distal tube.There were bends throughout the proximal wire core.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 other similar complaints reported from this lot.Based on the information received and analysis of the returned device, the investigation was unable to determine a cause for the reported difficult to remove.It may be possible that, during the procedure, the pressurewire was inadvertently bent/kinked while attempting to advance through challenging anatomical morphology.Furthermore, it may be possible that the noted bend/kink on the pressurewire caused it to become inadvertently lodged in the narrow lesion resulting in the reported difficult to remove.However, this could not be confirmed.Although the pressurewire was returned stretched, bent and kinked in multiple areas, the reported separation was not 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: 16381993
• MDR Text Key: 309610456
• Report Number: 2024168-2023-01528
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/16/2023

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: 05/31/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20601G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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