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 RUBY COIL LP RBYLP0430 manufactured by Penumbra, Inc..

Event Text Entries

[188372965] The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report numbers: 1. 3005168196-2020-00472, 2. 3005168196-2020-00473, 3. 3005168196-2020-00474, 4. 3005168196-2020-00475, 5. 3005168196-2020-00477 6. 3005168196-2020-00478, 7. 3005168196-2020-00479, 8. 3005168196-2020-00480.
Patient Sequence No: 1, Text Type: N, H10

[188372966] The patient was undergoing a coil embolization procedure in the abdominal aortic using packing coil lps, ruby coil lps, lp system detachment handle (handle), and a non-penumbra microcatheter. During the procedure, the physician advanced a packing coil lp to the target vessel using the microcatheter and made multiple attempts to detach it using the handle. However, the attempts were unsuccessful, and it was observed that the black alignment zone on the handle had minimal separation; subsequently, the physician used their fingers to pin and pull the pusher assembly of the packing coil lp to manually detach it. In the middle of the procedure, a ruby coil lp (f94634) was found kinked upon removal from the packaging hoop. The damage to the ruby coil lp was found prior to use, and therefore, it was not used in the procedure. The physician then continued the procedure, and the issue with the packing coil lp occurred with three additional packing coil lps and two ruby coils lps. Another handle was opened and used with attempts to detach the coils, but it is unknown at which point the second handle was used; therefore, the coils were also manually detached using the pin and pull technique. It was reported that one of the handle made a weak sound upon pulling the trigger. In addition, the distal tip of the microcatheter was not initially visible, which led to the pusher assemblies of the ruby coil lps exiting the microcatheter and kinking in the coil pack. Once the physician was closer to the origin of the inferior mesenteric artery (ima), the tip of the microcatheter became visible. The procedure was completed using two additional ruby coil lps, a third handle, and the same microcatheter. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3005168196-2020-00476
MDR Report Key9908826
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

Generic NameHCG, KRD
Product CodeHCG
Date Received2020-03-31
Model NumberRBYLP0430
Catalog NumberRBYLP0430
Lot NumberF94630
Device AvailabilityN
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


Patient NumberTreatmentOutcomeDate
10 2020-03-31

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