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

Catalog Number C12059

Device Problems Break (1069); Communication or Transmission Problem (2896)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of signal calibration failure could not be confirmed due to device conditions.Functional testing and electrical testing could not be performed due to corrosion at the male connector area and separation at the distal tube; however, it was still held together by the corewire.There is no information reported that indicates the separation occurred during the procedure.However, the noted damages such as bend/kink, bunched material, twisted material, and separation at the distal tube is likely due to the circumstances of the procedure.It is likely that during the preparation, the pressurewire was attempted to be inserted into a device accessory (ie.Introducer needle) with difficulty which could be caused by the device accessory itself.As a result, the pressurewire is likely to be removed with difficulty which could lead to separation, bunched material, and other noted damages.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 signal calibration failure.However, it is likely that the reported issue was related to the noted damages.It is likely that the noted damages caused an intermittent open circuit which could cause the reported signal calibration failure; 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 the pressurewire x - wireless device could not be connected despite several attempts.The transmitter lighting pattern was steady yellow.Calibration could not be performed; and therefore, the device was not used in the patient and the procedure was completed with a new pressurewire x - wireless device.There was no patient involvement and no clinically significant delay in the procedure.The device return analysis revealed that the distal tube of the pressurewire x - wireless device was separated 7.7cm proximal to the sensor jacket but held by the core.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: 17391439
• MDR Text Key: 319708102
• Report Number: 2024168-2023-07983
• 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: 07/25/2023

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: 12/31/2023
• Device Catalogue Number: C12059
• Device Lot Number: 20103G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• 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