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

Model Number	FG-06551-101
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was described as: "it was a left cfa puncture for a right leg angiogram.Upon removal of the fortress 6f 45cm sheath resistance was encountered.Sheath was attempted to be withdrawn, but it was noted that the sheath was stretching.Upon realization, a 6f 65cm fortress was opened, in order to get the 65cm introducer.It was managed to insert the introducer into the sheath and removed it.Nb: clinical nurse stated that the delivery of the sheath over the iliac bifurcation was uneventful.Fortress valve and side port were replaced with another distributor's valve and side port, as there had been a separate issue with other companies stent accidently deploying in the fortress sheath.Therefore, this part of the fortress sheath needed to be removed and replaced.This event occurred well before the attempt to remove the fortress sheath." event occurred: inside patient.Patient injury: no.Patients outcome: discharged at home.On 23.10.2024 customer provided additional information: "i have spoken with the scrub nurse who said that the 6f fortress 45cm sheath distal end was in the aorta when they encountered resistance when pulling back the sheath.They were removing it without the dilator which is their normal practice unless there is resistance.When they encountered resistance, they also noticed that the sheath was a lighter blue than normal at the insertion site, and this is when they stopped and opened a 65cm fortress sheath and inserted the dilator from it to retrieve the 45cm sheath.".
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.
Event or Problem Description
The problem was described as: "it was a left cfa puncture for a right leg angiogram.Upon removal of the fortress 6f 45cm sheath resistance was encountered.Sheath was attempted to be withdrawn, but it was noted that the sheath was stretching.Upon realization, a 6f 65cm fortress was opened, in order to get the 65cm introducer.It was managed to insert the introducer into the sheath and removed it.Nb: clinical nurse stated that the delivery of the sheath over the iliac bifurcation was uneventful.Fortress valve and side port were replaced with a cook valve and side port, as there had been a separate issue with other companies stent accidently deploying in the fortress sheath.Therefore, this part of the fortress sheath needed to be removed and replaced.This event occurred well before the attempt to remove the fortress sheath." event occurred: inside patient patient injury: no patients outcome: discharged at home.On 23.10.2024 customer provided additional information: "i have spoken with the scrub nurse who said that the 6f fortress 45cm sheath distal end was in the aorta when they encountered resistance when pulling back the sheath.They were removing it without the dilator which is their normal practice unless there is resistance.When they encountered resistance, they also noticed that the sheath was a lighter blue than normal at the insertion site, and this is when they stopped and opened a 65cm fortress sheath and inserted the dilator from it to retrieve the 45cm sheath.".
Additional Manufacturer Narrative
Initial report submitted on 18 nov 2024, per mfr report #: 3003637635-2024-00022.The dhr review and investigation performed on the returned device showed that there is no production or design issue that can lead to the defect which caused the complaint case.According to the additional information provided by the customer, the dilator was not used during sheath removal.According to the ifu of the device, dilator usage during withdrawal is a must.The root cause has been established as user error.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F STRAIGHT 45CM
• 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: 20703826
• Report Number: 3003637635-2024-00022
• Device Sequence Number: 13164411
• Product Code: DYB
• UDI-Device Identifier: 04251244503703
• UDI-Public: 04251244503703
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG-06551-101
• Device Catalogue Number: 386594
• Device Lot Number: 800515
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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