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

Catalog Number C12059

Device Problems Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that when connecting the pressurewire x (pwx) to the coroventis system, the transmitter blinks yellow and green.Another pwx was not attempted.No patient was involved.Device analysis found the distal tube of the returned pressurewire x was torn 3cm proximal to the sensor jacket for approximately 3mm.There was reportedly no post procedure manipulation of the wire by the site.No additional information was provided.

Manufacturer Narrative

Visual, functional, and electrical testing were performed on the returned device.The reported event of flashing yellow/green lights was confirmed.The device failed to calibrate and it displayed the reported light pattern.Electrical testing was performed and it revealed that there was a wet insulation error on the guidewire.It was also noted that there was a tear on the distal tube which may cause the insulation error.It was also noted that there were multiple bends on the proximal tube; however, this is likely due to handling during the procedure.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 flashing green/yellow light is likely due to the noted insulation error which is likely caused by the noted tear on the distal tube.It is possible that during preparation, the distal tube was inadvertently torn due to interaction with another device resulting in an insulation error and the reported issue.The insulation error may result in unstable pressure readings during calibration; as a result, it would trigger the light pattern as reported.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: 18143085
• MDR Text Key: 328197388
• Report Number: 2024168-2023-12710
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2023

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 Catalogue Number: C12059
• Device Lot Number: 30615G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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