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

Catalog Number	RBY4C0201
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	01/18/2019
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 to treat an arteriovenous malformation using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil within its introducer sheath and, consequently, the pusher assembly became kinked.Therefore, the ruby coil was removed, and the procedure was then completed using additional ruby coils with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly was kinked approximately 8.0 cm, 10.5 cm, 31.0 cm, 43.0 cm, 46.0 cm, 84.0 cm, 88.0 cm, 112.0 cm and 114.0 cm from the proximal end.The embolization coil was intact with the distal detachment tip (ddt) of the pusher assembly.The introducer sheath was ovalized approximately 53.0 cm and 64.0 cm from the distal end.The introducer sheath was kinked approximately 62.0 cm from the proximal end.During functional testing resistance was encountered at the kinked location of the introducer sheath while advancing the ruby coil and the device could not advance any further.Conclusions: evaluation of the returned ruby coil revealed a kink along its introducer sheath.If the device is forcefully manipulated while the introducer sheath is inserted into a rotating hemostasis valve (rhv), the introducer sheath may become kinked.This damage likely contributed to the reported inability to advance the ruby coil out of its introducer sheath.Further evaluation revealed kinks along the pusher assembly and ovalizations along the introducer sheath.Some of these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 8346163
• Report Number: 3005168196-2019-00290
• Device Sequence Number: 2105677
• Product Code: HCG
• UDI-Device Identifier: 00814548013114
• UDI-Public: 00814548013114
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/18/2019
• 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 Expiration Date: 03/13/2026
• Device Catalogue Number: RBY4C0201
• Device Lot Number: F82356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005