MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC STEERABLE INTRODUCER SHEATH 12F

Model Number	SS120065
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the sheath during a patient procedure the balloon ruptured in the heart.The patient's chest had to be opened so the that the device could be manually removed.The patient is reportedly stable after the procedure.

• Brand Name: STEERABLE INTRODUCER SHEATH 12F
• Common Device Name: STEERABLE INTRODUCER SHEATH
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8976
• MDR Report Key: 11796590
• Report Number: 1000121130-2021-00001
• Device Sequence Number: 17105382
• Product Code: DRA
• UDI-Device Identifier: 00850004312049
• UDI-Public: 00850004312049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192422
• 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 faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: SS120065
• Device Catalogue Number: PN1008533-004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/10/2021
• 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: Required Intervention