MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 4F, 45 CM, MULTIPACK

Model Number	FG-04551-101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was described as: "durant une intervention endovasculaire, nous avons utilisé deux introducteurs de 4f longs fortress (même lot: 800441), le premier était défectueux car le mandrin de rentrait pas aisément dans l'introducteur et le deuxième s'est complètement détruit lorsque la chirurgienne a tenté de le retirer de l'artère iliaque gauche.Il nous semble que le dispositif est complètement ressorti, bien que en plusieurs morceaux mais possibilité de débris restants dans la patiente.During an endovascular procedure, we used two fortress long 4f introducers (same lot: 800441), the first of which was defective because the dilator did not fit easily into the introducer and the second was completely destroyed when the surgeon tried to remove it from the left iliac artery.It seems to us that the device came out completely, albeit in several pieces, but there is a possibility of debris remaining in the patient."l'incident a-t-il effectivement eu des conséquences graves pour le patient, l'utilisateur ou un tiers ?: non.Did the incident have serious consequences for the patient, user or third party?: no.Veuillez décrire les consequences graves possibles et indiquer la raison pour laquelle l'incident est considéré come grave: risque de corps étranger.Risque de conversion en chirurgie ouverte.Risque d'embolie.Please describe the possible serious consequences and indicate the why the incident is considered serious: risk of foreign body.Risk of conversion to open surgery.Risk of embolism.
Additional Manufacturer Narrative
The problem description indicates that multiple devices (2) were involved in the incident.It should therefore be noted that the manufacturer has concluded that only one of the two devices may have contributed to this mdr reportable event.Therefore, a separate report related to the other device will not be submitted.The complaint device will not be returned for an evaluation.It was discarded by the healthcare facility.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of root cause investigation.The root cause of the incident is unknown at the time of the initial report.
Additional Manufacturer Narrative
Initial report submitted on 05 february 2025, per mfr report #: 3003637635-2025-00002.The complaint devices was not returned.Therefore testing of the actual device in the reported adverse event 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 underminable.
Event or Problem Description
The problem was described as: "durant une intervention endovasculaire, nous avons utilisé deux introducteurs de 4f longs fortress (même lot: 800441), le premier était défectueux car le mandrin de rentrait pas aisément dans l'introducteur et le deuxième s'est complètement détruit lorsque la chirurgienne a tenté de le retirer de l'artère iliaque gauche.Il nous semble que le dispositif est complètement ressorti, bien que en plusieurs morceaux mais possibilité de débris restants dans la patiente.During an endovascular procedure, we used two fortresses long 4f introducers (same lot: 800441), the first of which was defective because the dilator did not fit easily into the introducer and the second was completely destroyed when the surgeon tried to remove it from the left iliac artery.It seems to us that the device came out completely, albeit in several pieces, but there is a possibility of debris remaining in the patient." l'incident a-t-il effectivement eu des conséquences graves pour le patient, l'utilisateur ou un tiers? non.Did the incident have serious consequences for the patient, user or third party? no.Veuillez décrire les consequences graves possibles et indiquer la raison pour laquelle l'incident est considéré come grave: risque de corps étranger.Risque de conversion en chirurgie ouverte.Risque d'embolie.Please describe the possible serious consequences and indicate the why the incident is considered serious: risk of foreign body.Risk of conversion to open surgery.Risk of embolism.On 22.01.2025, customer provided additional information as below: "unfortunately, they (hospital) haven't kept the devices.I don't have more information than the introducers broke, but no part of the device remained inside the patient.".

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 4F, 45 CM, MULTIPACK
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL; 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: 21312444
• Report Number: 3003637635-2025-00002
• Device Sequence Number: 18363805
• Product Code: DYB
• UDI-Device Identifier: 04251244503604
• UDI-Public: 04251244503604
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K100799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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-04551-101
• Device Catalogue Number: 358814
• Device Lot Number: 800441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: Required Intervention
• Patient Sex: Unknown