MAUDE Adverse Event Report: EAST END MEDICAL I SAFECROSS TRANSSEPTAL RF PUNCTURE AND STEERABLE BALLOON INTRODUCER SYSTEM

Model Number	3002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: as-received sample was investigated there were signs of activation of rf energy near the tip sheath (on the circumference) with a burn mark at the tip.However, functional testing revealed balloon leak/rupture on the diametrically opposite side of the rf energy activation mark.The sample was dissected along the 90' axis (perpendicular to the rf energy mark) and cut open.There were signs of weakening and stretching of extrusion layer.The balloon leak matched with this weakened area.The balloon was mounted correctly.Manufacturing records review: review of the manufacturing and qc records show the device passed all quality criteria and manufactured according to specifications.In addition, the supplier of the component conducted in-process control charts and confirmed the product was manufactured according to the specification.The manufacturer has done the due diligencce and completed all possible investigations.Ifu review/conclusion interviews with the user physician by the field team indicate that the rf puncture member was activated sub-planar to the balloon and kept active for 'longer time'.The ifu directs users to activate rf energy on the superior plane to the balloon and for 2 secs at a time under warning section.There is a possibility that extended rf energy activation while being subplanar to the balloon likely weakened and stretched the area of the inner extrusion (heat exposure inside the device).The transeptal puncture procedure itself was successful and no adverse impact to the patient was reported.
Event or Problem Description
During a transseptal procedure for a bmv (valvuloplasty) , the sis balloon reportedly ruptured/bursted.Procedure was successful.Patient was fine.No impact to the overall workflow.Returning the product to the manufacturer for further review.

• Brand Name: SAFECROSS TRANSSEPTAL RF PUNCTURE AND STEERABLE BALLOON INTRODUCER SYSTEM
• Common Device Name: SAFECROSS TRANSSEPTAL RF PUNCTURE AND STEERABLE BALLOON INTRODUCER SYSTEM
• Manufacturer (Section D): EAST END MEDICAL I; 10320 usa today way; miramar FL 33025
• Manufacturer (Section G): EAST END MEDICAL; 10320 usa today way; miramar FL 33025
• Manufacturer Contact: mani shanmugham ; 10320 usa today way; miramar, FL 33025 ; 9545077887
• MDR Report Key: 14465847
• Report Number: 3021558379-2022-00001
• Device Sequence Number: 17437168
• Product Code: DYB
• UDI-Device Identifier: 08600035053020
• UDI-Public: 08600035053020
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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 Model Number: 3002
• Device Catalogue Number: 3002
• Device Lot Number: 2203005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown