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

Model Number	SSNF
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not available for evaluation.The device history was reviewed and found no anomalies.Proper materials and methods of manufacturing were utilized.There is no indication of a relation between the adverse event and the performance of the device.If additional information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the transseptal puncture was performed during an atrial fibrillation ablation procedure utilizing the safesept needle free transseptal guidewire along with a competitor dilator and introducer sheath to gain access to the left atrium, the dilator punctured the left atrial appendage.As a result, heart surgery with a sternotomy was performed to close the atrial appendage.No further patient complications have been reported as a result of this event.

• 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: 8190245
• Report Number: 3013986346-2018-00001
• Device Sequence Number: 2118319
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)210501(11)180517(10)000340
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: SSNF
• Device Catalogue Number: SSNF
• Device Lot Number: 000340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/21/2018
• 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: SL1 DILATOR (MANUFACTURED BY ST. JUDE/ABBOTT)
• Outcome Attributed to Adverse Event: Required Intervention