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

Catalog Number	RBY2C1857
Medical Device Problem Codes	Positioning Failure (1158); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was wrinkled but intact on the proximal end of the pusher assembly.The ruby coil was fractured approximately 7.5 cm from the proximal end of the device and kinked approximately 10.5 cm from the proximal end of the device.The embolization coil had offset coil winds near the center of the coil and was intact with its proximal constraint sphere.The embolization coil was detached from its pusher assembly and the pull wire was retracted proximally from the distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil revealed a device with a detached embolization coil and a kinked and fractured pusher assembly.If the device pusher assembly is kinked, it may contribute to a buildup of friction inside the pusher hypotube and prevent the embolization coil from detaching.Upon retracting the ruby coil, it may have reduced the friction, allowing the pull wire to retract from the distal detachment tip (ddt) and allow the embolization coil to detach.The root cause of the initial kink was unable to be determined.Further evaluation shows the pet lock was wrinkled.This is likely due to the reported multiple attempts to detach the ruby coil using the handle.This further supports that there may have been a buildup of friction that was too strong for the detachment handle to overcome.Further evaluation revealed a fracture on the pusher assembly and offset coil winds on the embolization coil.Based on the returned condition and the reported complaint, the fracture and offset coil winds were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 3005168196-2018-01768.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully placed multiple ruby coils using a microcatheter.The physician then was unable to detach a ruby coil using the handle and, therefore, the ruby coil was removed.The procedure was completed using additional coils.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: 7857488
• Report Number: 3005168196-2018-01767
• Device Sequence Number: 11257903
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/10/2018
• 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: 03/13/2026
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F82340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• 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: 08/10/2018
• Initial Report FDA Received Date: 09/07/2018
• 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