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

Model Number SSNF

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

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 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
• Type of Device: NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Manufacturer (Section D): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• Manufacturer Contact: andrew armour ; 1 school street; morton, PA 19070 ; 6102859858
• MDR Report Key: 8190245
• MDR Text Key: 131178839
• Report Number: 3013986346-2018-00001
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)210501(11)180517(10)000340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL1 DILATOR (MANUFACTURED BY ST. JUDE/ABBOTT)
• Patient Outcome(s): Required Intervention