MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F, 45 CM, CURVED

Model Number	FG-06553-001A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The 6fr fortress sheath was attempted to be removed but was found to have resistance.The sheath was noted to have broken while in the vessel.Device failed (e.G.Broke, couldn't get it to work or stopped working).Patient injury: no.Did device parts remain in the patient? no.Event occurred: inside patient.
Additional Manufacturer Narrative
The complaint device will not be returned for an evaluation.Therefore, testing of the actual device in the reported case is not possible.The dhr/batch record review showed that there is no production or design issue that can lead to the defect which caused the complaint case.Root cause is undeterminable.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F, 45 CM, CURVED
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse. 37; dresden 01277 ; GM 01277
• Manufacturer Contact: juliana vaz nuernberger ; lauensteiner strasse. 37; dresden 01277 ; GM 01277
• MDR Report Key: 20531400
• Report Number: 3003637635-2024-00020
• Device Sequence Number: 15127771
• Product Code: DYB
• UDI-Device Identifier: 04251244503727
• UDI-Public: 04251244503727
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K153197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: FG-06553-001A
• Device Catalogue Number: 386593
• Device Lot Number: 800160
• 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: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown