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

Model Number X

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Separation (1562)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of faulty pressure registration could not be confirmed.The results of the investigation were inconclusive.Functional testing and electrical testing could not be performed due to the guidewire conditions.The distal tip coil had been stretched, separated, and kinked.The distal tube had also been kinked.Additionally, the material at the male connector area had been torn.There is no information reported that indicates the damage occurred during the procedure.It is likely that the damage occurred during post-procedure handling.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 was unable to determine a cause for the reported faulty pressure registration.It may be possible that procedural contaminants/contrast on the pressure sensor membrane contributed to the reported pressure registration issue; however, 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.

Event Description

It was reported that on (b)(6) 2022, the pressurewire x, wireless was used in left anterior descending artery with 70 percent pre-stenosis.The pd pressure was small and equalization could not be achieved.Several attempts were made, with no success.A replacement pressurewire x, wireless was used to complete the procedure.There were no adverse patient effects or clinically significant delay in procedure.On 6/21/22 return device analysis noted that the core of the pressurewire x was separated 2.5cm distal to the sensor.Follow-up information from the account stated the user was not sure when the separation occurred.No additional information was provided.

• 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: 14932152
• MDR Text Key: 295964891
• Report Number: 2024168-2022-07205
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/06/2022

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: 02/28/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 10301G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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