MAUDE Adverse Event Report: ABBOTT VASCULAR HT PROGRESS GUIDE WIRE

Catalog Number UNK HT PROGRESS 40

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

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Occlusion (1984); Perforation (2001); Vasoconstriction (2126)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Event date: date estimated.The patient deaths referenced will be filed under a separate medwatch report #.The additional devices referenced in b5 will be filed under separate medwatch report numbers.There was no reported device malfunction and the product was not returned.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review for this product was not performed since the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of perforation, dissection, occlusion, and infection are listed in electronic instructions for use guide wire hi-torque progress, as known patient effects of the procedure.A conclusive cause for the reported perforation, intimal dissection, occlusion, hypersensitivity, hemorrhage, vasoconstriction, hypotension, hypertension, and infection and the relationship to the product, if any, cannot be determined.The reported treatment(s) of additional therapy non-surgical treatment and hospitalization appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Article title: post market clinical follow-up evaluation report polymer guide wires.

Event Description

It was reported through a research article identifying whisper, pilot, and progress guide wires that may be related to the following: patient death, myocardial infarction, perforation, dissection, occlusion, allergic reaction, bleeding, vasoconstriction, hypotension, hypertension, infection, revascularization, and rehospitalization.This article summarizes clinical outcomes of 950 patients that were treated with whisper, pilot, and progress guide wires.Specific patient information is documented as unknown.Details are listed in the article, titled "post market clinical follow-up evaluation report polymer guide wires.".

• Brand Name: HT PROGRESS GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10718854
• MDR Text Key: 212521588
• Report Number: 2024168-2020-08840
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091825
• 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: 10/22/2020

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 HT PROGRESS 40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/22/2020
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR