MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number UNK CROSS-IT XT

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

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Vasoconstriction (2126)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Estimated event date.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional wiggle wire guide wire referenced in the pmcf is filed under a separate medwatch report number.

Event Description

It was reported through a post market clinical follow up evaluation report identifying the ht cross-it xt guide wire that may be related to the following: dissection, vasoconstriction, vasospasm, infection, hemorrhage, hypotension, hypertension, failure to advance.Details are listed in the article, titled post market clinical follow-up (pmcf) evaluation report stainless steel guide wires.

Manufacturer Narrative

A2: median.A3: majority.B3: estimated.D4: no udi is being reported since the part and lot numbers were not reported.There was no reported device malfunction and the product was not returned.A review of the lot history and similar incident review for this product was not performed as the part and lot numbers were not reported and the product was not returned.It should be noted that the reported patient effects of infection and dissection are listed in the instructions for use as known patient effects of the procedure.A conclusive cause for the reported infection, vasoconstriction, hypotension, hypertension, intimal dissection and hemorrhage and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment titled: post market clinical follow-up (pmcf) evaluation report stainless steel guide wiresh2 correction: corrected pmcf report attached.

• Brand Name: ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10862449
• MDR Text Key: 216941907
• Report Number: 2024168-2020-09679
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K990639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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 CROSS-IT XT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR