MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE INDUSTRIES, INC.; LEFT HEART SMGH-LF 2

Model Number DYNJ41932F

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

Guidewire not advancing.

Manufacturer Narrative

It was reported " a.038 guidewire would not pass through the end of 18g cutiing needle.The operator tried several times felt she was up against the wall of the artery and had to remove the needle and wire.Patient was coagulated and manual pressure applied for 12 mins.New 18g needle used".No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Manufacturer Narrative

Investigation conclusion code was updated.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LEFT HEART SMGH-LF 2
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17337090
• MDR Text Key: 319386566
• Report Number: 1423395-2023-00033
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10195327326210
• UDI-Public: 10195327326210
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ41932F
• Device Catalogue Number: DYNJ41932F
• Device Lot Number: 23CBW275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other