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

Model Number	RBYLP0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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: 3005168196-2021-01609, 3005168196-2021-01610, 3005168196-2021-01611.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortic sac using ruby coil lps, lp system detachment handles (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp to the target vessel using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp.Next, the physician advanced a new ruby coil lp to the aneurysm sac and attempted to detach it using a new handle, but the ruby coil lp failed to detach.It was reported that the ruby coil lp did not detach even though the black segment on the back of the pusher assembly was separated into two black lines.Therefore, the physician attempted to manually detach the ruby coil lp; however, it was unsuccessful.It was also reported that the pusher assembly was snapped a couple more times, but the coil still did not detach.Therefore, the ruby coil lp was removed.An angiogram was performed and showed that the endoleak had stopped and no further coiling was needed; therefore, the procedure was completed at this point.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortic sac using ruby coil lps, lp system detachment handles (handle), a non-penumbra coil and a non-penumbra microcatheter.During the procedure, the physician advanced a non-penumbra coil to the target vessel using the microcatheter and attempted to detach it; however, the non-penumbra coil failed to detach.Therefore, the physician removed the non-penumbra coil.The physician then advanced a ruby coil lp to the target vessel using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the physician manually detached the ruby coil lp.Next, the physician advanced a new ruby coil lp to the aneurysm sac and attempted to detach it using a new handle, but the ruby coil lp failed to detach.It was reported that the ruby coil lp did not detach even though the black segment on the back of the pusher assembly was separated into two black lines.Therefore, the physician attempted to manually detach the ruby coil lp; however, it was unsuccessful.It was also reported that the pusher assembly was snapped a couple more times, but the coil still did not detach.Therefore, the ruby coil lp was removed.An angiogram was performed and showed that the endoleak had stopped and no further coiling was needed; therefore, the procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: 1.Section d.Box 10.Device available for evaluation? (do not send to fda) 2.Section h.Box 3.Reason for non-evaluation 3.Section h.Box 3.''other'' reason for non-evaluation please note that the following section is being updated based on additional information provided by a penumbra sales representative on (b)(6)2021: 1.Section b.Box 5.Describe event or problem 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: 1.3005168196-2021-01609 2.3005168196-2021-01610 3.3005168196-2021-01611 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: 12201078
• Report Number: 3005168196-2021-01612
• Device Sequence Number: 17253488
• Product Code: HCG
• UDI-Device Identifier: 00815948021747
• UDI-Public: 00815948021747
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/05/2021
• 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: 03/02/2026
• Device Model Number: RBYLP0202
• Device Catalogue Number: RBYLP0202
• Device Lot Number: F104303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005