MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; FORCEPS IN CATH LAB DRAPE PACK-LF

Catalog Number	DYNJ0378596F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery.Reportedly, this occurred as the cardiologist was using the forceps to spread the patient's skin after making an incision.Manual pressure was "held for hemostasis" over the puncture site.The patient was not under general anesthesia at the time of this incident.The procedure did not last longer than expected.There was no reported impact to the procedure, the patient, or the patient's stability.After an unidentified period of time a femoral ultrasound was performed with no adverse findings reported.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery.

• Common Device Name: FORCEPS IN CATH LAB DRAPE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7887313
• Report Number: 1423395-2018-00044
• Device Sequence Number: 2489032
• Product Code: OES
• UDI-Device Identifier: 10889942063024
• UDI-Public: 10889942063024
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/18/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0378596F
• Device Lot Number: 18GBN757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: 61 YR
• Patient Weight: 79