MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F STRAIGHT 90 CM

Model Number	FG-06558-001
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complained device will not be returned for an evaluation.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of root cause investigation.
Event or Problem Description
Heavily calcified iliacs.(b)(6) advanced the fortress 6x90 sheath and was able to complete the intervention of the three target lesions/vessels (right pop, peroneal and pta).Upon completion of the case (b)(6) removed the fortress sheath but the last 10cm broke off inside of the patient in the common femoral artery.(b)(6) advised there was a lot of scar tissue in the common femoral.The patient had to be taken to the hospital for open surgery to remove the 10cm of the fortress sheath that broke off.Surgery was successful and the broken piece of the sheath was removed.Vessel tortuosity: moderate.Calcification of vessel: severe.
Additional Manufacturer Narrative
The device was not returned back to the manufacturer for the evaluation.There is no previous sheath came apart complaint received for the same lot number (713416).No systemic failure for the same lot has been found.The description of the event from the health care professional states the patient condition as heavily / severe calcified iliacs, lot of scar tissue in the common femoral and moderate vessel tortuosity.The production record (dhr) was checked.There was found no abnormalities for the produced lot related to the complaint case in the dhr review.The further investigation was not possible as the reported device was not returned for evaluation.Therefore, the true root cause(s) could not be determined.The review of dhr did not reveal manufacturing related failure.Based on the available information there is also no indication that the event was caused by a design related failure.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F STRAIGHT 90 CM
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 17182048
• Report Number: 3003637635-2023-00002
• Device Sequence Number: 15076908
• Product Code: DYB
• UDI-Device Identifier: 04251244500603
• UDI-Public: 04251244500603
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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 Expiration Date: 10/31/2025
• Device Model Number: FG-06558-001
• Device Catalogue Number: 444481
• Device Lot Number: 713416
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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 Age: 61 YR
• Patient Sex: Male