PENUMBRA SMART COIL 400SMTXSFT2H04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PENUMBRA SMART COIL 400SMTXSFT2H04 manufactured by Penumbra, Inc..

Event Text Entries

[188373748] This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report numbers: 1. 3005168196-2020-00469, 2. 3005168196-2020-00471.
Patient Sequence No: 1, Text Type: N, H10


[188373749] The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter and a non-penumbra stent device. During the procedure, the physician used the stent device to hold open the vessel, then, the smart coil was successfully implanted into the target vessel using the handle and microcatheter. While advancing the next smart coil through the microcatheter, the physician encountered resistance but was able to reach the target location. After making an attempt to detach the smart coil using the handle, the physician was unsure whether it detached or not, and made an attempt to manually detach it. The physician was still unsure whether the smart coil truly detached; therefore, it was withdrawn. Upon removal of the pusher assembly, the physician realized that the smart coil had detached in the microcatheter; therefore, it was completely removed. The next smart coil was advanced approximately 10 centimeters into the same microcatheter and became stuck. The physician suspected that the microcatheter was occluded and decided to remove the smart coil and flush the microcatheter on the back table. While flushing the microcatheter, a small residue covered in blood emerged. Subsequently, the same microcatheter was re-advanced into the target vessel. While advancing the next smart coil through the microcatheter, the physician encountered resistance and upon removal, noticed that the pusher assembly had kinked in a "wave" form. The smart coil was discarded. Upon further analysis, the pusher assembly of all three complaint coils exhibited the same kinking. The procedure was completed using another smart coil, the same handle, the same microcatheter, and the same stent device. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00470
MDR Report Key9908099
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-05
Date of Event2020-03-05
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-05
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
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 NamePENUMBRA SMART COIL
Generic NameHCG, KRD
Product CodeHCG
Date Received2020-03-31
Model Number400SMTXSFT2H04
Catalog Number400SMTXSFT2H04
Lot NumberF91798
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 Received2020-03-31
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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