MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; HEART CATH PACK

Model Number	DYNJ61294D
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The facility reported that the guide wire within the pack "shredded" inside the patient.No additional details were provided related to the customer reported issue.
Additional Manufacturer Narrative
The facility reported that the guide wire within the pack "shredded" inside the patient.No additional details were provided related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was returned to the manufacturer for evaluation.During visual inspection the guidewire was noted to be completely out of its plastic vendor packaging and the wire was extremely frayed and pulled apart.The coating of the wire was not flaking off and the end of the wire frayed and split apart, causing the wire to shred apart and uncoil from itself.A definitive root cause could not be determined at this time.No additional information is available.Due to the reported incident and 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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: HEART CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13441855
• Report Number: 1423395-2022-00003
• Device Sequence Number: 11283802
• Product Code: OEZ
• UDI-Device Identifier: 10193489305401
• UDI-Public: 10193489305401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ61294D
• Device Catalogue Number: DYNJ61294D
• Device Lot Number: 21KBH501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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