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

Catalog Number	RBY2C1035
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.During the procedure, the physician was unable to advance a ruby coil out of its introducer sheath and, therefore, the ruby coil was removed.The physician then attempted to advance the ruby coil within its introducer sheath on the back table, however, was unable to.The procedure was then completed using a new ruby coil.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 embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusion: evaluation of the returned ruby coil revealed a fully functional device.During functional testing, the ruby coil was advanced out of its introducer sheath and through a demonstration catheter without issue.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8575455
• Report Number: 3005168196-2019-00857
• Device Sequence Number: 13998819
• Product Code: HCG
• UDI-Device Identifier: 00814548019062
• UDI-Public: 00814548019062
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 04/03/2019
• 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: 08/21/2026
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F85425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005