POD PACKING COIL RBYPODJ60

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for POD PACKING COIL RBYPODJ60 manufactured by Penumbra, Inc..

Event Text Entries

[185230252] This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10


[185230253] The patient was undergoing a coil embolization procedure in the splenic artery using a pod packing coil (podj) and a lantern delivery microcatheter (lantern). It was reported that the patient anatomy was tortuous. During the procedure, the physician advanced a podj into the target vessel using the lantern and needed to reposition the podj. While repositioning the podj, it unintentionally detached inside the lantern; therefore, the lantern containing the detached podj was removed and the podj was flushed out. The procedure was completed using a new podj and the same lantern. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00419
MDR Report Key9861820
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-02-26
Date of Event2020-02-26
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VERONICA FARRIS
Manufacturer StreetONE PENUMBRA PLACE
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer Phone5107483200
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePOD PACKING COIL
Generic NameHCG, KRD
Product CodeHCG
Date Received2020-03-20
Catalog NumberRBYPODJ60
Lot NumberF93544
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-20
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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