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

Model Number	RBY4C0415-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
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 number: 3005168196-2020-01915.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils, pod packing coils (pod pcs), and a lantern delivery microcatheter (lantern).During the procedure, the lantern was introduced to the target vessel and penumbra coils were implanted.While advancing a ruby coil through the lantern, the physician noticed that the ruby coil pusher assembly was bent and did not allow for smooth advancement.Therefore, the ruby coil was removed.Next, the same issue occurred with a pod pc.Therefore, the pod pc was also removed.The procedure was completed using additional ruby coils.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 intact with its pusher assembly and had offset coil winds.During functional testing, the ruby coil was re-sheathed with slight resistance due to the offset coil winds.The ruby coil was then advanced through a demonstration lantern without an issue conclusions: evaluation of the returned ruby coil could not confirm the reported bend in the pusher assembly.Further evaluation of the returned ruby coil revealed offset coil winds on the embolization coil.This damage was likely incidental to the reported complaint.During the functional test, the ruby coil was advanced through a demonstration lantern without an issue.Evaluation of the returned pod pc confirmed that the pusher assembly was kinked.The kink is likely the reported bend in the pusher assembly.If the pod pc is forcefully advanced against resistance, damage such as kinks may occur.During the functional test, the pod pc was advanced through a demonstration lantern with resistance due to the kinks in the pusher assembly.Further evaluation of the returned pod pc revealed offset coil winds on the embolization coil.This damage likely incidental to the reported complaint.Penumbra coils are visually 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.This report is associated with mfr report number: 1.3005168196-2020-01915.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10802853
• Report Number: 3005168196-2020-01914
• Device Sequence Number: 3799799
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/12/2020
• 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 Expiration Date: 07/31/2024
• Device Model Number: RBY4C0415-A
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F70929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005