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

Model Number	RBY2C1035-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
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.This report is associated with mfr report number: 1.3005168196-2020-00679.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using ruby coils, a ruby coil detachment handle (handle) and, a lantern delivery microcatheter (lantern).During the procedure, the physician detached a ruby coil in the target vessel using a handle; however, the pusher assembly of the ruby coil became stuck in the handle.Therefore, the handle and the pusher assembly of the ruby coil were removed.Next, while advancing a ruby coil through the lantern, the ruby coil unintentionally detached inside of the lantern.Therefore, the physician used the pusher assembly of the ruby coil to push the detached ruby coil into vessel.The procedure was then completed using a new handle, additional ruby coils, other coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was damaged but intact and slipped off of the hypotube and the pull tube was retracted from the proximal end of the pusher assembly.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached and not returned for evaluation.Conclusions: evaluation of the returned handle confirmed that the pull tube from the ruby coil used in the procedure was stuck within the device.If the handle is repeatedly actuated during use, damage such as this may occur.The nose cone was removed from the handle body and the nose cone funnel was measured and was within specification.The handle was tested on a handle test fixture and performed within specification.The handle was then used to successfully detach a demonstration ruby coil.Evaluation of the returned ruby coil pusher assembly revealed that the pet lock was damaged but intact and was slipped off of the hypotube and the pull tube was retracted from the proximal end of the pusher assembly.If the device is forcefully mishandled during use, damage such as this may occur.If this occurs, the embolization coil will detach from the pusher assembly.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 1.3005168196-2020-00679.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10097434
• Report Number: 3005168196-2020-00680
• Device Sequence Number: 3406214
• Product Code: HCG
• UDI-Device Identifier: 00814548019062
• UDI-Public: 00814548019062
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020
• 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: RBY2C1035-B
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F94366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005