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

Model Number SSNF

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Manufacturer (Section D): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• MDR Report Key: 8977712
• MDR Text Key: 206985888
• Report Number: 3013986346-2019-00001
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)240301(11)190328(10)000529
• Combination Product (y/n): N
• PMA/PMN Number: K172893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER; TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR