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

Catalog Number	RBY2C0420
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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.During the procedure, while advancing a ruby coil through a lantern delivery microcatheter (lantern), the ruby coil unintentionally detached from its wire.Therefore, the lantern 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 lantern.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 pusher assembly was kinked at approximately 6.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured, and the embolization coil was unraveled.The proximal constraint sphere and the pull wire were within the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured, and the embolization coil was unraveled.Further investigation revealed that the proximal constraint sphere and pull wire were within the pusher assembly ddt.If the embolization coil is forcefully retracted against resistance, damage such as an sr wire fracture may occur, and the embolization coil may unravel.The lantern used in the procedure was not returned for evaluation; therefore, the root cause of the resistance was unable to determined.Further investigation revealed a kink on the pusher assembly.This damage was likely incidental to the 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8980985
• Report Number: 3005168196-2019-01715
• Device Sequence Number: 3287827
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• 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): 08/12/2019
• 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: 01/18/2025
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F73883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 09/10/2019
• 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
• Date Report Sent to FDA: 01/01/2005