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

Catalog Number C12059

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

Visual, functional, and electrical testing were performed on the returned device.The reported event of pressure signal drift could be confirmed.The device could not calibrate due to open circuits in the male connector area.There were bends/kinks on the male connector, proximal tube, distal tube, and corewire of the distal tip.There was also a fracture on the proximal tube; however, the guidewire was still held together by the corewire.It is likely the bends/kinks occurred due to mishandling or excessive force during use.Based on the returned conditions, it is also likely while transporting the device to abbott for the return analysis, the kink on the guidewire became separated/fractured due to stress received during shipping.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 pressure signal drift was due to the noted open circuit.It is likely the damage (such as bends/kinks) to the guidewire due to mishandling or excessive force occurred during preparation/advancement resulting in the noted open circuit.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 the pressurewire x - wireless device was to be used in an unspecified artery.However, non-compliant values in the resting full cycle ratio (rfr) measurement were displayed, even after repeating the equalization process.It is unknown at this time how the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.Return device analysis revealed that the ptfe coating was broken at 45 cm distal to the proximal tip, with the corewire remaining intact.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, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18196277
• MDR Text Key: 328981994
• Report Number: 2024168-2023-12984
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: C12059
• Device Lot Number: 11101G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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
• Patient Sex: Male