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

Model Number X

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

It was reported that the pressurewire x - wireless was calibrated and equalized normally.The device was to be advanced to a lesion in the left anterior descending (lad) artery with heavy calcification and heavy tortuosity for resting full-cycle ration (rfr) measurement.However, there was difficulty while advancing and manipulating the device into the lesion.Then while applying the torque and pushing the device into the lesion, the shaft part of the device became kinked.It was noted that a <6f sheath was used against instructions for use.The device was removed and another pressurewire x wireless device was to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.The device return analysis revealed that the distal tube (hydrophillic coating) material was torn 25.5cm proximal to the distal tip.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported failure to advance was not able to confirm as it was based on procedural circumstances.The kink was confirmed.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.Information from the field stated that the pressurewire was used with a guiding catheter smaller than 6f.The pressurewire instructions for use (ifu) directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.In this case, it could not be determined if using a smaller sized guiding catheter caused or contributed to the reported difficulties.The investigation determined that the reported failure to advance resulting in a kink and tear of the hydrophilic coating noted at the kink was likely related to circumstances of the procedure.It is likely that the failure to advance and kink was caused by interaction with the heavy calcification and heavy tortuosity.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.(b)(4).

• 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: 15514166
• MDR Text Key: 306407060
• Report Number: 2024168-2022-10180
• 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
• Report Date: 09/29/2022

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: 03/31/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20420G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2022
• 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