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

Model Number	DYNJ41932F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire not advancing.
Additional 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.
Additional Manufacturer Narrative
Investigation conclusion code was updated.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: 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
• Report Number: 1423395-2023-00033
• Device Sequence Number: 20485122
• Product Code: OEZ
• UDI-Device Identifier: 10195327326210
• UDI-Public: 10195327326210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Model Number: DYNJ41932F
• Device Catalogue Number: DYNJ41932F
• Device Lot Number: 23CBW275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown