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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, STRAIGHT 45 CM, 6F

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CONTRACT MEDICAL INTERNATIONAL, GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, STRAIGHT 45 CM, 6F Back to Search Results
Model Number FG-06551-001A
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Patient Problems Edema (1820); Hemostasis (1895); Numbness (2415); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
The dhr review of the complaint lot 654478 and related subassembly lots 654394, 658166, 656669, 656670 and 653512 was performed and there was found no deviation which could contribute to the reported incident. The device passed all 100% in process inspection and aql based inspections. The manufacturer informed manufacturing operators and qc inspectors about the complaint. No remedial actions were initiated at the time of the initial report, since the exact root cause was not determined yet. Since at the beginning limited information was provided by the customer to the manufacturer, an additional questions were raised by the manufacturer, which should help during investigation. It seems, based on the information regarding the incident received so far that the device was used in contradiction with the intended use of the device, described in the ifu. The indications in the ifu says following: "the fortress introducer sheath system is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other device into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures. " it was confirmed by the customer, that an area of the treatment was the anterior interventicular artery. The access point was the radial. Since the device got broken, there was no functional valve which could stop the bleeding.
 
Event Description
Event description provided by customer representative: "the fortress 6f intriducer broke outside the patient during withdrawal. As it was bleeding a lot the arteria had to be clamped. Then it was tried to remove the introducer sheath again but the fortress broke inside the patient again. Therefore the patient had to be send to another hospital for emergency. " event detailed description according biotronik complaint notification form id: (b)(4). "via radial artery. The fortress 6f introducer (45cm) broke outside the patient at withdrawal. Arteria was spasme-associated. So the withdrawal was difficult, but it happens often. As the valva was out of order, it was bleeding a lot. The physician needed to clamp the arteria. He tried again to remove the introducer but it broke again inside the patient. The patient has been hospitalized in another hospital in emergency. Today the patient suffers from an edema in the forearm and paresthesia also in the forearm. The patient is still at hospital. ".
 
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Brand NameBIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, STRAIGHT 45 CM, 6F
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, 01277
GM 01277
Manufacturer Contact
jan kloboucnik
lauensteiner strasse 37
dresden, 01277
GM   01277
MDR Report Key9443137
MDR Text Key219791008
Report Number3003637635-2019-00005
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K153197
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberFG-06551-001A
Device Catalogue Number386594
Device Lot Number654478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2018
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: 12/10/2019 Patient Sequence Number: 1
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