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

Model Number	RBY2C0825-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, after the lantern was inside the patient, the physician encountered resistance while introducing the first ruby coil.Subsequently, the ruby coil pusher assembly became kinked.Therefore, the ruby coil was removed.The procedure was completed using the same lantern and twenty-three additional coils including ruby coils, pod packing coils (pod pcs), and pod 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 pusher assembly was kinked approximately 41.0 cm, 130.0 cm, and 131.0 cm from the proximal end.The pusher assembly was fractured approximately 42.0 cm from the proximal end.The pull wire was retracted form the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned ruby coil pusher assembly confirmed a kink and revealed a fractured near the kink.If the device is forcefully advanced against resistance, the pusher assembly may become kinked and subsequently fracture may occur.If the pusher assembly is fractured and the pull wire is retracted from the ddt, the embolization coil will detach from the pusher assembly.Due to the fractured pusher assembly, the functional testing was unable to be performed; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the device revealed additional kinks on the pusher assembly.This damage was 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: 10691237
• Report Number: 3005168196-2020-01773
• Device Sequence Number: 3934009
• Product Code: HCG
• UDI-Device Identifier: 00814548018850
• UDI-Public: 00814548018850
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 09/24/2020
• 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: RBY2C0825-B
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F95350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005