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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 65CM 5F STRAIGHT

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CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 65CM 5F STRAIGHT Back to Search Results
Model Number FG-05557-001
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  Death  
Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report. The complained device has not been evaluated yet. The manufacturer performed dhr review of the complaint lot 686650 and subsequent sub-assemblies lots 688513, 677554 and 668589. No non-conformance, deviation or other abnormality relating to this event were found in the records.
 
Event Description
Dr (b)(6) used a fortress 5 x 65 sheath (item number: 444484, lot: 686650); as the introducing sheath was being removed for closure, dr (b)(6) realized the biotronik sheath frayed (was coming apart) inside the patient, which required double access in an attempt to snare, a quick decompensation of the patient which required a call to 911 and transfer to emergency room. This device has been saved for you for further investigation. Used a turbo laser 1. 4 for the atherectomy.
 
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Brand NameBIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 65CM 5F STRAIGHT
Type of DeviceINTRODUCER 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, germany 01277
GM 01277
Manufacturer Contact
juliana nuernberger
lauensteiner strasse 37
dresden, germany 01277
GM   01277
MDR Report Key14774472
MDR Text Key294500653
Report Number3003637635-2022-00002
Device Sequence Number1
Product Code DYB
UDI-Device Identifier04251244500573
UDI-Public04251244500573
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153197
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFG-05557-001
Device Catalogue Number444484
Device Lot Number686650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2022 Patient Sequence Number: 1
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