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

Model Number	RBYLP0430
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 numbers: 3005168196-2021-00607, 3005168196-2021-00608.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps and a non-penumbra microcatheter.During the procedure, three ruby coil lps would not advance from the friction lock within the introducer sheath.Therefore, all three ruby coil lps was removed.The procedure was completed with new ruby coil lps.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Further evaluation revealed an ovalization on the introducer sheath near the friction lock.This damage may have been a result of forceful gripping of the introducer sheath during advancement against resistance.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then additional resistance was experienced due to the ovalization in the introducer sheath, and the ruby coil lp could not advance any further.Evaluation of the second returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kink near the mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then additional resistance was experienced due to the pusher assembly kink, and the ruby coil lp could not advance any further.Evaluation of the third returned ruby coil lp revealed that the pusher assembly was fractured and had kinks, the pusher assembly mid-joint was retracted through the proximal end of the introducer sheath, and the embolization coil was detached from the pusher assembly within the introducer sheath.This damage was not mentioned in the reported complaint and is likely incidental.Due to the return condition, the reported complaint could not be confirmed.The root cause of the reported complaint could not be determined.Penumbra coils 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of ruby coil lp advancement issue this report is associated with mfr report numbers: 1.3005168196-2021-00607, 2.3005168196-2021-00608.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11579656
• Report Number: 3005168196-2021-00609
• Device Sequence Number: 14317851
• Product Code: HCG
• UDI-Device Identifier: 00815948021822
• UDI-Public: 00815948021822
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 03/01/2021
• 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: 12/16/2025
• Device Model Number: RBYLP0430
• Device Catalogue Number: RBYLP0430
• Device Lot Number: F102821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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