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

Catalog Number C12059

Device Problems Improper or Incorrect Procedure or Method (2017); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the pressurewire x package was torn which compromised sterility.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported opened pouch or sterility breach could not be confirmed as the pouch was inadvertently discarded during the inventory process when the device was received.As a result, a visual inspection of the pouch could not be performed.There were bends/kinks on the male connector, proximal tube, and corewire of the distal tip; however, the damage is likely due to the normal use of wire during the procedure or due to transport to abbott for the return analysis.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.Information from the field stated that the pouch of pressurewire was noted to be opened.The pressurewire instructions for use (ifu) states that "the pressurewire x guidewire is supplied sterile.Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier".In this case, the device was not used inside the patient.The investigation could not determine the cause of the reported opened pouch or sterility breach as the pouch was inadvertently discarded during the inventory process.It may be possible there was an insufficient sterile barrier.It may also be possible that the sterile pouch was damaged due to stressful transport conditions or incautious handling.However, without examining the pouch, these could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: 2017 device code clarifier- use after damage.

Event Description

Subsequent to the previously filed report, additional information reported that the pressurewire x was attempted to be used in the procedure after sterility breach.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: 17546493
• MDR Text Key: 321200306
• Report Number: 2024168-2023-08768
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: C12059
• Device Lot Number: 10918G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2021
• 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