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 Problem Vascular Dissection (3160)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported in this article titled, "treatment of slow-flow after primary percutaneous coronary intervention with flow-mediated hyperemia: the randomized rain-flow study" that there was one patient who had a proximal dissection in the left circumflex artery caused by the pressurewire x.This patient was treated according to the study protocol (with flow-mediated hyperemia) after treatment of the coronary dissection with stent implantation without further complications.Results from the rain-flow (treatment of slow-flow after primary percutaneous coronary intervention with flow-mediated hyperemia) study were discussed in this article.There were 67 patients with st-segment¿ elevation myocardial infarction and no reflow were randomized to receive either pharmacologic-mediated hyperemia with intracoronary adenosine or nitroprusside (n=30) versus flow-mediated hyperemia (n=37).Study enrollment was from january 23, 2021 to november 9, 2022.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.A2: mean age was 67.7±12.3 years.B3: estimated date.The udi number is unknown as the part and lot #s were not provided.Article title attached: treatment of slow-flow after primary percutaneous coronary intervention with flow-mediated hyperemia: the randomized rain-flow study.

Manufacturer Narrative

B3: date of event estimated.D4 - udi #: the udi number is unknown as the part and lot numbers were 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 product was not returned for evaluation and the part and lot numbers were not reported.In this case, there was no reported device malfunction associated with the pressurewire.The reported patient effect of vascular dissection is listed in the pressurewire instruction for use as a known potential complication which may be encountered during all catheterization procedures.In this case, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.A definitive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The unexpected medical intervention 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 e-181178 article titled: treatment of slow-flow after primary percutaneous coronary intervention with flow-mediated hyperemia: the randomized rain-flow study.

• 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: 17865664
• MDR Text Key: 324867188
• Report Number: 2024168-2023-10809
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/27/2023

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?: 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: Not provided
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/27/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male