MAUDE Adverse Event Report: PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

Model Number	SSNF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A procedure was performed using the safesept needle free (ssnf).When removing the wire from the introducer, it was noticed that the distal "j" portion of the wire was missing.The device history was reviewed and found no anomalies.Proper materials and methods of manufacturing were utilized.The unit was not returned for analysis.If additional information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the user was unable to cross the septum.The wire was removed from the cannula, and it was noticed that the distal end was missing.

• Brand Name: SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Common Device Name: NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Manufacturer (Section D): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• MDR Report Key: 9644694
• Report Number: 3013986346-2020-00001
• Device Sequence Number: 16875851
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)240801(11)190807(10)000625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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 Expiration Date: 08/01/2024
• Device Model Number: SSNF
• Device Catalogue Number: SSNF
• Device Lot Number: 000625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1