MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM; INTRODUCER, CATHETER

Model Number	45 CM, 6F CROSSOVER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Towards end of angiogram, surgeon had difficulty removing 6fr fortress sheath from patient's right femoral artery.New dilator given per surgeon request.Surgeon able to remove sheath.Sheath appeared to have damage to outside material, a malfunction.X-ray tech notified.Surgeon states all parts from damaged sheath accounted for.No sheath parts left in patient.Damaged sheath w/dilator was placed in biohazardous bag along with 2nd sheath that was opened.Defective device given to x-ray tech.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; 5030 centerville road; saint paul MN 55127
• MDR Report Key: 11444786
• Report Number: 11444786
• Device Sequence Number: 19737642
• Product Code: DYB
• UDI-Device Identifier: 04251244500092
• UDI-Public: (01)04251244500092
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 02/09/2021

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: 45 CM, 6F CROSSOVER
• Device Catalogue Number: 386593
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/09/2021