MAUDE Adverse Event Report: MEDTRONIC; MEDTRONIC LINE IN DBD-OPEN HEART CDS

Catalog Number	CDS983965D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.Reportedly, the break occurred while peeling back the line's securement tape.When the break was identified, the remaining part of the line was clamped and the exposed end was covered.The medtronic set cath placement pressure line was required to be removed via an unidentified surgical procedure.No impact or adverse effect to the patient or the patient's stability was reported to the pack manufacturer.No sample for evaluation was returned to the pack manufacturer.Due to the need for medical intervention to remove the medtronic set cath placement pressure line, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.

• Common Device Name: MEDTRONIC LINE IN DBD-OPEN HEART CDS
• Manufacturer (Section D): MEDTRONIC; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8579703
• Report Number: 1423395-2019-00017
• Device Sequence Number: 16877735
• Product Code: OEZ
• UDI-Device Identifier: 10889942885961
• UDI-Public: 10889942885961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDS983965D
• Device Lot Number: 18GBQ946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Weight: 8