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); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that the pressurewire x, wireless device was used in the left anterior descending (lad) artery with moderate tortuosity.It was noted that a <6f sheath was used against instruction for use.Resistance was felt with the lesion when attempting to advance.Prior to crossing the lesion, the tip of the device was noted to be tearing, but remained in one piece.Therefore, the device was removed and an unspecified device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code 2017 failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.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 issue.It was reported that the pressurewire was used with a guiding catheter smaller than 6f.It should be noted that the pressurewire x, instructions for use states: "use the pressurewire x guidewire in conjunction with a 6f (2 mm diameter) guiding catheter".Based on the reported information and results of the complaint investigation there is no indication that the reported difficult to advance resulting in torn material is related to a product quality issue with respect to the design, manufacture, or labeling of the device.In this case, it is likely that challenging anatomical condition or severe calcification/angulation caused damaged such as the reported torn material, bend, or kink.As a result, the damage affected the maneuverability to navigate resulting in the reported difficulty advancing.

• 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: 18349203
• MDR Text Key: 330832403
• Report Number: 2024168-2023-14171
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)250630(10)30713G1
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/18/2024

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: 30713G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2023
• 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