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

Catalog Number	RBY2C0530
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
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.During the procedure, the physician advanced a ruby coil out of the lantern delivery microcatheter (lantern) and into the target vessel but decided to retract the coil for repositioning.While attempting to re-advance the ruby coil through the lantern, the physician experienced resistance and was unable to advance the coil.Upon manipulation, the ruby coil unintentionally detached from its pusher assembly inside the lantern.Therefore, the physician removed the lantern containing the detached coil, then flushed the coil out and reinserted the lantern into the patient's body.The procedure was then successfully 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 embolization coil was detached from the pusher assembly, had a fractured stretch resistant (sr) wire.The proximal constraint sphere was missing, and the pull wire was inside the distal detachment tip (ddt) capture feature.Conclusions: evaluation of the returned ruby coil revealed the sr wire was fractured, and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach.The root cause of the resistance experienced could not be determined.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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: 6664612
• Report Number: 3005168196-2017-00991
• Device Sequence Number: 71887
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 05/26/2017
• 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: Physician
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F64609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005