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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS CONVERTIBLE VENATECH FILTER

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B. BRAUN MEDICAL SAS CONVERTIBLE VENATECH FILTER Back to Search Results
Catalog Number 5010028
Device Problems Migration or Expulsion of Device (1395); Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/12/2020
Event Type  Injury  
Event Description

When deploying the convertible filter, a stabilizing leg got caught in the sheath and the filter ended up in the junction between the right atrium and the svc. The patient suffered no clinical adverse event from the deployment and a venatech lp filter was placed from the femoral approach without incident. Placed via the jugular approach. Filter location: supra-renal. The patient has not undergone surgery since the filter placement. Time frame of event: during implant. The patient suffered no adverse clinical event where the convertible filter is lodged. The patient is fine as described by physician. Updated information: indication for filter placement: pe when anticoagulant is contraindicated. There was a central line in place when the filter was implanted. Deployment level: the convertible filter was deployed in the correct place (below the renal veins) but the filter was pulled by the sheath (when the sheath was removed). While the sheath was being removed, a filter leg was caught in the sheath. Then the physician pulled the filter and sheath back and the filter released from the sheath. The physician snared the filter to get it part way out of the heart.

 
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Brand NameCONVERTIBLE VENATECH FILTER
Type of DeviceVENATECH FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
26 rue armengaud
saint-cloud 92210
FR 92210
MDR Report Key10124094
MDR Text Key194163188
Report Number3006332832-2020-00005
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5010028
Device LOT Number36946554
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2020
Distributor Facility Aware Date05/14/2020
Event Location Hospital
Date Report TO Manufacturer05/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/05/2020 Patient Sequence Number: 1
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