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

Catalog Number	RBY4C0415
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
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 using ruby coils.During the procedure, while advancing a ruby coil through a non-penumbra microcatheter, the ruby coil unintentionally detached prior to reaching the target vessel.Therefore, the microcatheter containing the detached ruby coil was removed and the ruby coil was flushed out.The procedure was completed using a new ruby coil and the same microcatheter.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 ruby coil pusher assembly.The embolization coil was detached from the pusher assembly distal detachment tip (ddt) and had offset coil winds.The proximal constraint sphere was attached with the embolization coil.The pull wire was within the ddt.The inner diameter (id) of the ddt and outer diameter (od) of the proximal constraint sphere were within specification.The od of the pull wire was unable to be measured.The pet lock was broken by the penumbra investigator to test the pull wire compression.Due to coagulated blood inside the pusher assembly, functional testing was unsuccessful and the compression was unable to be tested.Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly, the pet lock was intact, and the pull wire was within the ddt.If the pusher assembly becomes elongated, the pull wire may retract enough to allow the coil to detach from the pusher assembly.Further investigation revealed offset coil winds along the length of the embolization coil.These offset coil winds were likely incidental to the complaint.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: 8925814
• Report Number: 3005168196-2019-01615
• Device Sequence Number: 253417
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 07/25/2019
• 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: 06/12/2024
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F70127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005