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

Model Number	RBY2C2060-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
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.This report is associated with mfr report number: 3005168196-2020-00084.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type i endoleak using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the ruby coil through the lantern into the target vessel; however, the physician was not satisfied with the result.Therefore, the ruby coil was retracted, re-sheathed and placed in a bowl of heparinized saline.Later in the procedure, the physician attempted to reuse the previously removed ruby coil and noticed that the ruby coil was kinked; therefore the ruby coil was not used.Next, a new ruby coil was placed successfully.The physician then advanced another ruby coil in the target vessel but decided to reposition the ruby coil; therefore, the ruby coil was removed, re-sheathed and rinsed in saline.While attempting to re-advance the ruby coil through the lantern, the physician experienced resistance; therefore, the ruby coil was removed and not used.The procedure was completed using another ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2020-00084.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9625512
• Report Number: 3005168196-2020-00083
• Device Sequence Number: 2774015
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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,Followup
• Report Date (Section B): 01/02/2020
• 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: RBY2C2060-B
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F92414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005