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

Model Number	RBYLP0315
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-01599, 3005168196-2021-01601.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coil lps and lp system detachment handle (handle).During the procedure, two ruby coil lps would not advance at all past their initial positions within their introducer sheaths.Therefore, the ruby coil lps were removed.During the same procedure, the physician was unable to detach another coil using the handle; therefore, a new handle was opened, and the coil was successfully detached.The procedure was completed using new ruby coil lp and new handle.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Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.After the mid-joint passed through the friction lock, the ruby coil lp was able to advance through its introducer sheath without an issue.Further evaluation of the device revealed pusher assembly kinks.This damage was likely incidental to the complaint.Evaluation of the second returned ruby coil lp revealed that the device was returned without its introducer sheath; therefore, the reported device would not advance from its initial position inside the introducer sheath could not be confirmed.The device was unable to be sheathed with a demonstration introducer sheath due to the kinks in the pusher assembly.Therefore, the device could not be functionally tested.The kinks in the pusher assembly were likely incidental to the complaint.Due to the returned condition, the root cause of the reported complaint could not be determined.Further evaluation of the device revealed offset coil winds on the embolization coil.This damage was likely incidental to the complaint and may have occurred due to the device being returned without the introduce sheath.Evaluation of the returned handle revealed a functional and an undamaged device.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration ruby coil lp without issue.Penumbra coils and handles are visually inspected and functionally tested during incoming inspection.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 reported ruby coil lp advancement issue.This report is associated with mfr report numbers: 1.3005168196-2021-01599.2.3005168196-2021-01601.H3 other text : placeholder.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12192377
• Report Number: 3005168196-2021-01600
• Device Sequence Number: 11133090
• Product Code: HCG
• UDI-Device Identifier: 00815948021792
• UDI-Public: 00815948021792
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 08/13/2021
• 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: 03/04/2025
• Device Model Number: RBYLP0315
• Device Catalogue Number: RBYLP0315
• Device Lot Number: F96731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005