PK PAPYRUS US 4.0/20 434896 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for PK PAPYRUS US 4.0/20 434896 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.

Event Text Entries

[186127051] A pk papyrus covered stent system was selected for treatment of a perforated vessel. 2 to 3 hours after treatment patient was in tamponade. Drains were inserted to relieve pressure. Ballooned proximal area was still leaking. The pk papyrus 4. 0/20 was deployed, still some leakage and it was continued to drain. Patient was discharged home next day and is well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2020-01505
MDR Report Key9908663
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-02-27
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-10-03
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8772459800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePK PAPYRUS US 4.0/20
Generic NameCOVERED CORONARY STENT
Product CodeNIV
Date Received2020-03-31
Model Number434896
Catalog NumberSEE MODEL NO.
Lot Number09192030
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK AG, BUELACH, SWITZERLAND
Manufacturer AddressACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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