MAUDE Adverse Event Report: ARGON MEDICAL DEVICES (MANAN MEDICAL PRODUCTS); INTRODUCER NEEDLE FROM CATH N0 1 STRL MMC PACK

Catalog Number	DYNJ46134C
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient, who was undergoing cardiac catheterization, required a second puncture to an unidentified artery after an initial unsuccessful attempt on the femoral artery using a dull gauge 18 introducer needle.Per report, a different introducer needle was used and the procedure continued without further incident.Additional sedation was reportedly not required.There was no report of any complications and no effect on the patient's stability as a result of the incident.No impact to the patient, the procedure, or the total length of the procedure was reported.There was no serious injury or follow up care reported related to the event.Due to the reported need for a second puncture and in an abundance of caution, this medwatch is being filed.The sample was returned and the reported complaint of dull introducer needle was confirmed.The manufacturer of the introducer needle has been notified of this incident.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a second puncture was required after an initial unsuccessful attempt using a dull introducer needle.

• Common Device Name: INTRODUCER NEEDLE FROM CATH N0 1 STRL MMC PACK
• Manufacturer (Section D): ARGON MEDICAL DEVICES (MANAN MEDICAL PRODUCTS); 241 palatine rd; wheeling IL 60090
• MDR Report Key: 7876496
• Report Number: 1423395-2018-00049
• Device Sequence Number: 16621544
• Product Code: OES
• UDI-Device Identifier: 10889942610822
• UDI-Public: 10889942610822
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: DYNJ46134C
• Device Lot Number: 18EDC167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• 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: 71 YR
• Patient Weight: 86