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

Model Number	SS-135
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/06/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that during a vt procedure, the aorta was perforated which required surgery and the patient subsequently died.The patient was high risk and had multiple morbidities.Based on communication with (b)(4) through our distributor in germany, (b)(4), it was communicated that the transseptal puncture attempt with the safesept wire did not correlate with the occurrence of tamponade on this case.The safesept was used as a safety technique for transseptal access and is the routine approach for fluoroscopy guided tsp.Inadvertent aortic root puncture by safesept was not followed by exchanging or protruding larger sheaths or needles and wire was retracted.No acute consequence occurred during the waiting period after failed tsp with the safesept.It is possible that mis-puncture occurred due to misinterpretation of fluoroscopic images.A review of lot001727 was conducted.All procedures were completed with no deviations noted, and all procedures were completed satisfactorily.
Event or Problem Description
It was reported that during a vt procedure, the aorta was perforated by the non-abbott wire (safesept) which required surgery and the patient subsequently died.The patient was high risk and had multiple morbidities.During transseptal puncture with the agilis sheath, brk needle, and a non-abbott (safesept wire), the physician punctured the aorta with the safesept.He immediately pulled back the wire.He tried again and this time the puncture was right, but he could not push the agilis dilator over the hole.He then tried a 3rd time and was able to do a successful transseptal puncture.After advancing the advisor hd grid catheter through the agilis sheath in the lv he asked the attending co physician to do a cardiac ultrasound.Thereby a pericardial effusion was diagnosed.Blood pressure dropped to 60/30.A pericardiocentesis was performed and the reanimation team and chief physicians and heart surgery were contacted.The chief of ep took over and was able to pull out large amounts of blood.Blood pressure stabilized to 120/80.The physician could not no longer remove any more blood.Protamin was given, however the pericardium was filling again with blood, which clotted and was not able to be pulled out.Blood pressure dropped to near zero.Cpr was then started.Cardiac surgeons opened the thorax and performed emergency surgery to find an unresponsive heart which had a perforated aorta.They were able to retrieve a big amount of coagulated blood surrounding the heart.Patient was then declared dead.Patient is now in pathology for obduction.The physician confirmed that the non-abbott device (safesept wire) punctured the aorta and the punctured aorta was the cause of the patient's death.There were no performance issues with any abbott device.

• Brand Name: SAFESEPT TRANSSEPTAL GUIDEWIRE
• Common Device Name: TRANSSEPTAL GUIDEWIRE
• Manufacturer (Section D): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• Manufacturer (Section G): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• MDR Report Key: 25255208
• Report Number: 3013986346-2026-00001
• Device Sequence Number: 20207648
• Product Code: DRC
• UDI-Device Identifier: 00858769006104
• UDI-Public: 00858769006104
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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 Model Number: SS-135
• Device Lot Number: 001727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown