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

Catalog Number	RBY2C0312-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
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 left internal carotid artery (ica) using ruby coils.During the procedure, the distal end of the ruby coil became kinked upon removal from the packaging hoop.The physician continued to advance the same ruby coil into the target vessel using a velocity delivery microcatheter (velocity); however, the physician was not satisfied with the positioning of the ruby coil in the vessel and decided to re-sheath the coil for repositioning.While advancing the ruby coil back through the velocity, the physician experienced resistance; however, the physician was able to complete the procedure with the same ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated at the proximal end of the pusher assembly.The pusher assembly had a bends at approximately 90.0 and 113.0 cm from the proximal end.The distal polymer section had bends approximately 11.0, 14.0, 20.0, and 27.0 cm from the distal tip.Conclusions: evaluation of the returned ruby coil pusher assembly revealed multiple bends on the pusher assembly.If the ruby coil is mishandled during removal from its packaging, damage such as bends may occur.If a bent ruby coil is used in a procedure, resistance may be experienced when manipulating the device.Due to the returned condition, it was unclear which of the bends was the reported damage to the device.The complaint report stated the embolization coil was successfully placed in the target anatomy.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: 8522720
• Report Number: 3005168196-2019-00716
• Device Sequence Number: 2817097
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 03/18/2019
• 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 Catalogue Number: RBY2C0312-A
• Device Lot Number: C07039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005