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

Model Number	FG-06551-001A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was described as: "the fortress introducer sheath is not sealed at the lower end.The sheath is not sealed at the bottom.This means that when the sheath is handed over and the outer non-sterile packaging is opened to open the sterile packaging, the sheath falls out by itself.The bottom seal is missing.Nothing has happened now.The sheaths just couldn't be used because they were no longer sterilely packaged and some of them had fallen to the floor.".
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint device will be returned for an evaluation.Information provided by the customer and the dhr review will be done as part of the root cause investigation.
Additional Manufacturer Narrative
Initial report submitted on 24 september 2024 per mfr report #: 3003637635-2024-00018.The complaint device was returned to the manufacturer.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.Visual inspection of the returned product showed no sign of a seal having been present which suggests that the sealing process of the inner pouch was missed by the operator performing the operations.Root cause therefore attributed to human error - omission.
Event or Problem Description
The problem was described as: "the fortress introducer sheath is not sealed at the lower end.The sheath is not sealed at the bottom.This means that when the sheath is handed over and the outer non-sterile packaging is opened to open the sterile packaging, the sheath falls out by itself.The bottom seal is missing.Nothing has happened now.The sheaths just couldn't be used because they were no longer sterilely packaged and some of them had fallen to the floor." on 08.10.2024, distributor updated the complained device amount as below; "due to the information received by the country representative, there were 5 units which were not sealed." 1 unit was returned for evaluation.4 additional units identified by the end user were not returned and discarded.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F, 45CM, STRAIGHT
• 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 neurnberger ; vazni 848; hradec kralove, 50003 ; EZ 50003
• MDR Report Key: 20290017
• Report Number: 3003637635-2024-00018
• Device Sequence Number: 20635169
• Product Code: DYB
• UDI-Device Identifier: 04251244503703
• UDI-Public: 04251244503703
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 800204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Patient Sex: Unknown