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

Model Number	RBY4C1035-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using ruby coils and lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was slightly tortuous.During the procedure, the physician experienced resistance while advancing a ruby coil through the lantern and, therefore, the physician decided to remove the ruby coil.While retracting, the ruby coil unintentionally detached inside of the microcatheter.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.The procedure was completed using pod packing coils (pod pc) and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed a detached embolization coil.Further evaluation revealed that the pet lock was separated, and the pull tube was retracted on the proximal end of the pusher assembly.If the ruby coil is forcefully mishandled during retracting from the microcatheter, damages such as these may occur.If the pet lock is separated, the pull wire inside the pusher assembly ddt may likely be retracted and allowed the embolization coil to detach from the pusher assembly.The kink which was observed near the distal tip of the pusher assembly 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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10039518
• Report Number: 3005168196-2020-00634
• Device Sequence Number: 2813337
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021
• 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: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/20/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 09/01/2021
• 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