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

Catalog Number C12059

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487); Material Separation (1562); Deformation Due to Compressive Stress (2889)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that during preparation, the pressurewire x wireless device was to be used in the left anterior descending (lad) artery.The device could not cross through ¿insertors.¿ the tip of the device became curved, bent and could not be reshaped after attempting to insert it and remove it, therefore the device was not used.A new pressurewire x device was used successfully for the procedure.There was no patient involvement and no clinically significant delays in the procedure.On 2/20/2024, returned device analysis found a core wire separation.The separation was located at 2.6 cm distal to distal end of the sensor jacket.The remaining core wire was noted to be missing.After follow up with the account, the following information was provided: the device could not cross through ¿insertors¿ which were attached to a device that was in the patient.The tip of the device became curved, bent and separated after attempting to insert it and remove it multiple times.A new pressurewire x device was used successfully for the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of separation and bend/kink could be confirmed.However, the reported event of difficulty in tip shaping and insertion could not be replicated in a testing environment as it was based on operational circumstances.A separation was noted on the corewire of the distal tip and the remaining corewire was noted to be missing.There were bends noted on the distal tip coil and corewire of the distal tip.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 determined that the reported issue was likely due to the circumstances of the procedure.It was reported that the wire could not be inserted into an accessory device ("insertors").It was likely that the diameter of the accessory device was less than 6f or there was obstruction inside or other factors that may cause difficulty for the pressurewire to be inserted.These factors likely caused damage such as bend/kink; as a result, the core lost its strength and integrity.It may also be possible that excessive force was used during insertion into the accessory device and it may lead to the noted separation and difficulty in tip shaping.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: 18858138
• MDR Text Key: 337136145
• Report Number: 2024168-2024-02916
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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 Catalogue Number: C12059
• Device Lot Number: 30223G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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