MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Model Number	RBY2C1035-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 number: 3005168196-2020-02291.
Event or Problem Description
The patient was undergoing a coil embolization in the pelvic vein using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the ruby coil through the lantern, the physician experienced resistance and subsequently, the ruby coil would not advance through the lantern.It was reported that the physician thought that the lantern was kinked.Therefore, the ruby coil and lantern were removed.After the removal, no kink on the lantern was noted.The procedure was completed using a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern revealed a distal shaft ovalization.If the device is forcefully gripped or pinched during used, damage such as an ovalization may occur.This ovalization likely contributed to the resistance experienced during the procedure.Evaluation of the returned ruby coil revealed offset coil winds along the length of the embolization coil and the embolization coil was detached and stuck inside the lantern.This damage was likely a result of forceful advancement the device against resistance.Further evaluation of the device revealed that the embolization coil was detached from its pusher assembly, the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was advanced distal to the ddt.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the coil to detach from the pusher assembly.This damage was likely incidental to the complaint.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 number: 3005168196-2020-02291.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11025374
• Report Number: 3005168196-2020-02292
• Device Sequence Number: 18999920
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2025
• Device Model Number: RBY2C1035-A
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F77795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005