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

Model Number	RBY4C1650-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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: 3005168196-2021-02042.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to advance two ruby coils through the microcatheter.Therefore, both ruby coils was removed.The procedure was completed using another coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil revealed that the sr wire was fractured, and the embolization coil was detached from its pusher assembly.Due to these damages, the reported complaint could not be confirmed.The probable cause of the reported issue could not be determined.If the ruby coil is forcefully retracted against resistance, damage such as an sr wire fracture may occur.The sr wire fracture likely resulted in the embolization coil detaching from its pusher assembly.Evaluation of the second returned ruby coil revealed that the device was unable to advance through a catheter, and the complaint was confirmed.The complaint indicated that the ruby coil was unable to be advance through a microcatheter.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint, and the root cause could not be determined.During the functional test, the ruby coil was unable to be advanced through a demonstration microcatheter due to the kinks in the pusher assembly.Penumbra coils are visually 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the inability to advance the ruby coil through the microcatheter this report is associated with mfr report number: 1.3005168196-2021-02042.H3 other text: placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12474501
• Report Number: 3005168196-2021-02043
• Device Sequence Number: 14675693
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 11/01/2021
• 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: 11/08/2024
• Device Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F72802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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