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

Catalog Number UNK PRESSUREWIRE X GUIDEWIRE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Vascular Dissection (3160)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated d4: the udi is unknown due to the part/lot number was not provided.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 part and lot numbers were not reported.In this case, there was no reported device malfunction associated with the pressure wire.The reported patient effects of vascular dissection and vessel spasm are listed in the pressure wire instruction for use as known potential complications which may be encountered during all catheterization procedures.A definitive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment with medications appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Literature attachment: article title: "safety of continuous coronary thermodilution measurements.

Event Description

The following information was received via literature review: this study aimed to evaluate the safety of continuous intracoronary thermodilution for assessment of the coronary microcirculation.The non-abbott catheter was used over a pressure wire x guide wire.Procedural complications referenced in this article potentially related to the pressure wire x guide wire included a dissection with no reported treatment and a coronary spasm which resolved after administration of intracoronary nitrates.The study concluded that the use of the non-abbott catheter for continuous intracoronary thermodilution¿derived measurements of absolute coronary flow and microvascular resistance is safe, with a very low rate of vascular complications that compares favorably with intravascular imaging.Details are listed in the attached article, titled "safety of continuous coronary thermodilution measurements".

• 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: 18677002
• MDR Text Key: 335020394
• Report Number: 2024168-2024-01650
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

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?: No
• 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: 01/31/2024
• Initial Date FDA Received: 02/09/2024
• 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
• Treatment: RAYFLOW CATHETER (HEXACATH)
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male