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	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A procedure was performed using the safesept needle free (ssnf).When removing the wire into the dispenser, 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.Scanning electron microscopy (sem) was used to analyze the fractured wire and concluded that the failure appears to be due to an overstress event caused by a shear force that was too strong for the wire alloy.If additional information is provided in the future, a supplemental report will be issued.
Event or Problem Description
This was a double transseptal procedure.The wire crossed without any issues.The physician was unable to cross the septum with the sheath.The wire, dilator, and cannula were removed, leaving the sheath in the right atrium.When removing the wire into the dispenser, it was noticed that the distal "j" portion of the wire was missing.Imaging was used and found that the "j" portion of the wire remained in the patient.
Additional Manufacturer Narrative
This follow-up report is to indicate why this submission was submitted past the 30-day mark.The information in this submission was submitted on 27jun2019.The acknowledgement letters were received and stated "delivered"; however, these letters were not downloaded to confirm successful delivery.The fda was contacted on 6sep2019 to understand why the submission was not on maude, and the process of reviewing the acknowledgement letters was explained.The original submission had a delivery failure due to excess characters in field d11.Therefore, the report was submitted again on 9sep2019 after the issue was corrected, and successful delivery was confirmed.
Event or Problem Description
This was a double transseptal procedure.The wire crossed without any issues.The physician was unable to cross the septum with the sheath.The wire, dilator, and cannula were removed, leaving the sheath in the right atrium.When removing the wire into the dispenser, it was noticed that the distal "j" portion of the wire was missing.Imaging was used and found that the "j" portion of the wire remained in the patient.

• 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: 8977712
• Report Number: 3013986346-2019-00001
• Device Sequence Number: 13530789
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)240301(11)190328(10)000529
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/01/2024
• Device Model Number: SSNF
• Device Catalogue Number: SSNF
• Device Lot Number: 000529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER; TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR