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

Model Number	RBY2C1440-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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: 3005168196-2020-01234.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak after an endovascular aortic repair (evar) stent implantation using a ruby coil, a lantern delivery microcatheter (lantern) and a ruby coil detachment handle (handle).During the procedure, the physician advanced the ruby coil into the target location using the lantern and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the ruby coil and handle were removed.The procedure was completed using a new ruby coil, a new handle, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly distal detachment tip (ddt) was fractured off the pusher assembly, and the embolization coil was detached and inside the introducer sheath.Offset coil winds were present throughout the length of the embolization coil.Conclusions: evaluation of the returned ruby coil revealed that the pet lock was intact on the proximal end of the pusher assembly.If the proximal end of the pusher assembly is not properly inserted into a handle, the pet lock may not separate when the handle is actuated, and the embolization coil will not detach.The handle identified in the complaint was not returned for evaluation.Further evaluation revealed that the pusher assembly ddt was fractured off the pusher assembly and the embolization coil was detached within the introducer sheath and had offset coil winds.If the ruby coil is forcefully retracted against resistance, damage such as this may occur.This damage was not mentioned in the reported complaint and may be incidental.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 coil failing to detach due to return damage.This report is associated with mfr report number: 1.3005168196-2020-01234 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: 10434964
• Report Number: 3005168196-2020-01233
• Device Sequence Number: 2344627
• Product Code: HCG
• UDI-Device Identifier: 00814548013039
• UDI-Public: 00814548013039
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020
• 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 Model Number: RBY2C1440-A
• Device Catalogue Number: RBY2C1440
• Device Lot Number: F93360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005