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

Model Number	RBY4C0630-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	11/18/2019
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 brachial artery using ruby coils.During the procedure, the physician experienced resistance while advancing the ruby coil within its introducer sheath; therefore, it was removed.The procedure was completed using new ruby coils.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 85.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.The embolization coil had offset coil winds along the distal end.Conclusions: evaluation of the returned ruby coil revealed offset coil winds on the distal end of the embolization coil.If the coil is forcefully advanced against resistance, damage such as offset coils may occur.Further evaluation revealed that the sr wire was fractured, and the embolization coil was detached from its pusher assembly.It was reported that the coil became stuck within the introducer sheath; however, the embolization coil was returned outside of its sheath, and detached from the pusher assembly.Therefore, the fractured sr wire is likely incidental and may have occurred when the coil was removed from the introducer sheath prior to return to penumbra.Penumbra coils are visually 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: 9493028
• Report Number: 3005168196-2019-02372
• Device Sequence Number: 13779263
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2019
• 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: RBY4C0630-A
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F91482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Date Report Sent to FDA: 01/01/2005