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

Model Number	X
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during an rfr [relative flow reserve] guided angioplasty, difficulty accessing the coronary artery with the pressurewire x wireless device was noted because the guide catheter did not provide enough support.The guide catheter was exchanged and when passing the pressurewire x wireless device, the polymer coating had come loose / unstable leaving the guide core exposed from the middle to proximal end.A new pressurewire x wireless device was used to complete the procedure.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported event of failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Meanwhile, the reported delaminated/peeled material could not be confirmed.However, a fracture was noted at the coated proximal tube region.The corewire was pulled out (separated) from the proximal tube but it was still intact which can result in the reported exposed guidewire core.Multiple kinks were also noted.It was likely that challenging anatomy, the interaction between the guidewire with other devices, or excessive manipulation/navigation in narrow vessel/stenosis caused damage to the guidewire resulting in material 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 identified no indication of a lot specific product quality issue.The investigation determined that the reported peeled material and failure to advance were likely related to the material separation at the proximal tube, and the reported issue was likely related to the circumstances of the procedure.It was likely the challenging anatomy, the interaction between the guidewire with other devices, or excessive manipulation/navigation in narrow vessel/stenosis caused damage to the guidewire resulting in material separation and difficulty to advance.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
• Common Device Name: 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: 13588345
• Report Number: 2024168-2022-01939
• Device Sequence Number: 20311451
• Product Code: DXO
• UDI-Device Identifier: 05415067025739
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: X
• Device Catalogue Number: C12009
• Device Lot Number: 10120G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG