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

Catalog Number C12059

Device Problems Difficult to Remove (1528); Material Separation (1562)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for 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 revealed no other similar incidents.The investigation determined that the reported difficulty to remove resulting in separation was likely related to procedural circumstances.It was reported that another wire was used with pressurewire x and they were reported to become entangled.It is likely that one of the wires was bent/kinked during advancement due to the challenging anatomical conditions; as a result, both wires were entangled during use which likely caused the reported separation during withdrawal.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 procedure was performed in the 85% stenosed, heavily tortuous, and moderately calcified lesion in the left anterior descending artery (lad).The lad was successfully cannulated.Subsequently, the pressurewire x wireless (pwx) was inserted through the guiding catheter to the distal lad.The guiding catheter was then removed from the ostium of the right coronary artery.While pulling the pwx back into the guiding catheter, a j tip wire was inserted into the 3.5/6 fr jr guiding catheter.During withdrawal of the j tip wire, the pwx became entangled with the j tip wire.When attempting to pull them apart, the pwx separated and remained attached to the guiding catheter.The pwx and the guiding catheter were removed together as a unit.There were no adverse patient effects and no clinically significant delay in the procedure.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 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: 18222056
• MDR Text Key: 329211329
• Report Number: 2024168-2023-13147
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 11/28/2023

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: 20106G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• Treatment: GUIDE CATHETER: 3.5/6 FR; GUIDE WIRE: J TIP
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Hispanic
• Patient Race: Asian