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

Model Number	RBY2C0312-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 111.5 cm from the proximal end and had additional bends on the proximal shaft.The embolization coil was detached from the pusher assembly within the introducer sheath.The introducer sheath was ovalized approximately 6.5 and 7.5 cm from its distal tip, and the embolization coil was damaged within the introducer sheath.The embolization coil distal tip was at the introducer sheath distal tip.Conclusions: evaluation of the returned ruby coil confirmed a pusher assembly kink.If the device is retracted from its packaging hoop at an extreme angle, damage such as a kink may occur.Subsequently, if the kinked device is advanced against resistance, the kink may worsen.Further evaluation revealed that the introducer sheath was ovalized in two locations on the distal shaft and the embolization coil was detached from the pusher assembly within the introducer sheath and was damaged at the ovalized location on the introducer sheath.This damage was likely incidental to the reported complaint and may have occurred after removal of the device from the procedure.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the geniculate artery using ruby coils and lantern delivery microcatheter (lantern).During the procedure, the pusher assembly of the ruby coil was found to be slightly bent upon removal from the dispenser hoop.Subsequently, while advancing the ruby coil into the lantern, the pusher assembly of the ruby coil bent in half; therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10995157
• Report Number: 3005168196-2020-02245
• Device Sequence Number: 3548623
• Product Code: HCG
• UDI-Device Identifier: 00814548018553
• UDI-Public: 00814548018553
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Report Date (Section B): 11/17/2020
• 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: RBY2C0312-B
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F88310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial 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
• Date Report Sent to FDA: 01/01/2005