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 03/01/2024

Event Type  malfunction  

Event Description

It was reported that during the procedure, the pressurewire x, (pwx) wireless failed to equalize.It is suspected the sensor is not working, the pressure curve went from flat to infinity.After several failed attempts to equalize, a new pwx was used without issue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned goods analysis observed a distal tube break.

Manufacturer Narrative

Visual and functional analysis were performed on the returned device.The reported faulty pressure registration could not be confirmed due to device conditions.Corrosion was noted on both the returned transmitter and wire components which likely due to liquid exposure during shipping back to abbott; as a result, functional testing could not be performed.A break was noted between the proximal and distal tubes; however, they are still held together by the corewire.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no indication of a lot specific product quality issues.The investigation determined that the reported faulty pressure registration is likely due to the noted break.In this case, it is likely that inadvertent damage (resulting in a break between proximal and distal tubes) occurred due to excessive force or mishandling during use.As a result, it may have caused an electrical issue inside the wire that could contribute to the reported issue.Based on the findings, 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: 19212654
• MDR Text Key: 341400339
• Report Number: 2024168-2024-05258
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)250731(10)30818G1
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/30/2024

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: 30818G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2023
• 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