MAUDE Adverse Event Report: MARTECH MEDICAL PRODUCTS INC; INTRODUCER NEEDLE FROM CATH LAB PACK

Catalog Number	DYNJ45005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a trans-thoracic procedure (direct stick to the aorta), the st.Jude/abbott.035/150 3mm j wire (ref# (b)(4)) got caught in the 18 gauge x 2.75 inches introducer needle, a component from the cath lab pack.Reportedly, after the guidewire was noted stuck in the needle, the physician successfully pulled the needle and guidewire out of the patient.There was no serious injury or follow-up care reported related to the event.The patient did not require additional sedation as a result of this incident.There was no impact to the patient, the procedure, or a staff member.The patient is reportedly doing well at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.A third party notification has been completed with the manufacturer of the introducer needle involved with this event.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a trans-thoracic procedure (direct stick to the aorta), the guidewire got caught in the introducer needle, a component from the cath lab pack.

• Common Device Name: INTRODUCER NEEDLE FROM CATH LAB PACK
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS INC; 1500 delp dr; harleysville PA 19438
• MDR Report Key: 7739137
• Report Number: 1423395-2018-00041
• Device Sequence Number: 16472910
• Product Code: OES
• UDI-Device Identifier: 10888277085428
• UDI-Public: 10888277085428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ45005
• Device Lot Number: 18DK1917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/01/2018
• 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: Other
• Patient Age: 82 YR
• Patient Weight: 68