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

Model Number	FG-06553-101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint devices will be returned for evaluation and investigation.The manufacturing record review including examination of nonconformity reports (ncr) and changes/deviates (eco/ ccid/deviation) will be done as part of root cause investigation.
Event or Problem Description
Event details: during the procedure, it was observed that the hemostatic valve did not seal completely.When additional guidewires, balloons, or other instruments were introduced, excessive blood flow occurred.As this issue has now appeared for the third time within the same lot, the entire lot has been collected for further inspection.Products that were used inside patients will not be returned.

• Brand Name: BIOTRONIK FORTRESS CROSSOVER INTRODUCER SHEATH, SINGLE PACKAGE, CURVED 45 CM, 6F
• 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, SPOL. S R.O.; vazni 848; hradec kralove, 50003 ; EZ 50003
• Manufacturer Contact: juliana vaz neurnberger ; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• MDR Report Key: 24434372
• Report Number: 3003637635-2026-00005
• Device Sequence Number: 10297938
• Product Code: DYB
• UDI-Device Identifier: 04251244503727
• UDI-Public: 04251244503727
• 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): 06/03/2026

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-06553-101
• Device Lot Number: 801804
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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