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

Catalog Number UNK PRESSUREWIRE X GUIDEWIRE

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported the procedure was performed in the left anterior descending artery with heavy calcification and tortuosity.The pressurewire x, wireless device was inserted, but was difficult to advance and had to be maneuvered by rotated back and forth during advancement.However, after a few turns, the physician felt the distal part of the device snap off.The distal part remained in the anatomy and was unable to be retrieved.A snare was inserted in an attempt to retrieve the tip, but was unable to do so.Therefore, a stent was implanted to trap the distal tip against the vessel wall.Patient was reportedly stable throughout.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported the investigation determined that the reported difficulty advancing and material separation were likely related to circumstances of the procedure.It is likely that torquing/maneuvering in heavy calcification or tortuosity resulted in material separation and difficulty advancing.It may also be possible that the distal tip is weakened due to excessive shaping of the tip or excessive force during the procedure; however, this could not be confirmed as it was based on operational circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

The device was not returned for analysis; however, cine was received and reviewed.The reported issue of material separation could be confirmed; however, a conclusive cause could not be determined from the media review.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported the investigation determined that the reported difficulty advancing and material separation were likely related to the circumstances of the procedure.It is likely that torquing/maneuvering in heavy calcification or tortuosity resulted in material separation and difficulty advancing.It may also be possible that the distal tip is weakened due to excessive shaping of the tip or excessive force during the procedure; however, without having the device examined, this could not be confirmed.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: 14632621
• MDR Text Key: 293717503
• Report Number: 2024168-2022-06109
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 07/11/2022

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 Catalogue Number: UNK PRESSUREWIRE X GUIDEWIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 07/11/2022
• Supplement Dates FDA Received: 07/11/2022; 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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