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

Model Number X

Device Problems Break (1069); Stretched (1601); Failure to Advance (2524)

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

Event Date 09/12/2022

Event Type  Injury  

Event Description

It was reported that the pressurewire (pw) x, wireless was used for ffr (fractional flow rate) measurement in the heavily tortuous, proximal right coronary artery.Sheath size was 6 french or greater.The pw was calibrated and equalized normally.It was advanced without resistance into the direction which was not intended and it was confirmed that the torque could not be applied on the tip of the pw on fluoroscopy.It was suspected that the pw core separated.The core was fractured but the outer coil remained intact with no separation, just stretched; therefore, it is not completely fractured.To avoid the complete separation of the pw, a non-abbott microcatheter was used to remove the pw.Another pw x, wireless was used to continue and complete the procedure with no adverse patient consequences.There was no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Na.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported failure to advance could not be confirmed in a testing environment as it was based on operational context; however, a stretch and a break were able to be confirmed which could contribute to the reported failure to advance.The break and stretch were noted at the distal tip coil but it was still intact.It was reported the break and stretch occurred during the procedure; however, the device was able to be retrieved using a microcatheter to avoid separation.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 complaints reported from this lot.The investigation could not determine a cause for the reported failure to advance, break, and stretch.It may be possible that the pressurewire was advanced to challenging anatomy which could damage the distal tip coil resulting in the reported issue; however, this could not be confirmed as it was based on the operational context.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: 15537620
• MDR Text Key: 301112802
• Report Number: 2024168-2022-10272
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 20314G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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
• Patient Outcome(s): Required Intervention