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); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problems Ischemia (1942); Foreign Body In Patient (2687)

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported the pressurewire x, (pwx), wireless was calibrated and equalized successfully.The device was to be used in the left anterior descending (lad) lesion.It was noted a <6f sheath was used against instruction for use.A drug-eluting stent (des) was previously implanted in the lad and left circumflex (lcx) lesions.There was difficulty advancing the pwx due to the vessel angulation in the lcx, and the pwx slightly kinked.When the pwx was pulled, it got stuck and could not be removed.A 6f guiding catheter and non-abbott micro catheter were used to try to remove the pwx, however, removal was still unsuccessful.When the pwx was pulled with the non-abbott catheter, the pwx separated in the aorta.The separated segment was attempted to be snared, however, ischemia got stronger.The blood flow was nearly cut off and timi was 0 or 1 at the location in which the pwx was stuck.A balloon was used multiple times to restore blood flow, however, blood flow was not completely recovered.The guiding catheter was changed to a 7f and a snare device was used in an attempt to retrieve the separated segment of the pwx into the guiding catheter, however, removal was still unsuccessful.A cutting balloon was used to cut the remaining segment of the pwx in the aorta from the left main trunk (lmt).Approximately 15cm from the tip remains free floating in the anatomy.The procedure was completed with intravascular ultrasound and a drug coated balloon.It is the physicians opinion, that the pwx got stuck with the previously implanted des in the lcx lesion.The patient was re-hospitalized and percutaneous coronary intervention was performed in the lad at a later date.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported event of material separation was confirmed.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 issues.The investigation determined that the reported material separation resulting in foreign body in patient and ischemia were likely related to procedural circumstances.It is likely that inadvertent damage such as bend/kink occurred due to challenging anatomical conditions (vessel angulation, calcification, etc); as a result, it reduced the maneuverability of the pressurewire and caused difficulty in advancing.It is likely that the distal tip got caught or entangled with the previously implanted stent which likely caused difficulty in removing.It was reported that a non-abbott catheter was used to retrieve the pressurewire, and it was noted during analysis that the non-abbott catheter was torn.The braiding of the non-abbott catheter tightly wrapped the distal tube of pressurewire.It is likely the braiding strangled the pressurewire resulting in the reported separation during the attempted removal.The medical intervention and prolonged hospitalization appear to be related to the circumstances of the procedure.Information from the field stated that the pressurewire was used with a guiding catheter smaller than 6f.The pressurewire instructions for use (ifu), directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.In this case, it could not be determined if using a smaller-sized guiding catheter caused or contributed to the reported difficulties.The reported patient effect of vessel occlusion (ischemia) is listed in the pressurewire x ifu as known potential complications which may be encountered during the procedure.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: 18013100
• MDR Text Key: 326631721
• Report Number: 2024168-2023-11887
• 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: 12/19/2023

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 Catalogue Number: C12059
• Device Lot Number: 30420G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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
• Treatment: IMPLANTED DES STENT; SHEATH: <6F
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG