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

Model Number	RBY2C1260-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and lantern delivery microcatheter (lantern).During the procedure, the physician placed two ruby coils in the target vessel using the lantern.While advancing the next ruby coil through the lantern, the physician experienced resistance; therefore, the ruby coil was removed.The procedure was completed using two additional ruby coils, a pod packing 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 pusher assembly.The pusher assembly was kinked approximately 81.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed offset coil winds on its embolization coil.If the device is forcefully advanced against resistance damage such as offset coil winds may occur.The lantern used in the procedure was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.During functional testing, the ruby coil was able to advance through a demonstration lantern without issue.Further evaluation revealed a pusher assembly kink.This kink was likely incidental to the complaint.Penumbra coils 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: 10115053
• Report Number: 3005168196-2020-00705
• Device Sequence Number: 1762856
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 05/14/2020
• 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 Expiration Date: 11/28/2023
• Device Model Number: RBY2C1260-A
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F66705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005