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

Model Number SS120065

Device Problem Material Rupture (1546)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 04/06/2021

Event Type  Injury  

Event 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
• Type of Device: STEERABLE INTRODUCER SHEATH
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8976
• Manufacturer (Section G): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8976
• Manufacturer Contact: larry bender ; 2301 centennial blvd; jeffersonville, IN 47130-8976 ; 8122802354
• MDR Report Key: 11796590
• MDR Text Key: 249669630
• Report Number: 1000121130-2021-00001
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00850004312049
• UDI-Public: 00850004312049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SS120065
• Device Catalogue Number: PN1008533-004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention