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

Catalog Number	RBY2C2457
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	01/25/2019
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 in the portal vein using ruby coils.During the procedure, a ruby coil would not advance past the rotating hemostasis valve (rhv); therefore, it was removed.The physician then attempted to advance the ruby coil out of its introducer sheath on the back table but resistance was encountered.Therefore, the procedure was completed using another ruby coil.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from its pusher assembly and had offset coil winds.The proximal end of the embolization coil was stuck inside the introducer sheath friction lock.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil was detached and had offset coil winds.The complaint indicated that the ruby coil could not advance past the rhv.If the introducer sheath is not properly aligned within the hub of the microcatheter, resistance may be encountered while advancing the coil.If the coil encounters resistance or becomes stuck in the rhv and is then forcefully advanced against that resistance, the coil winds may become offset.Further investigation revealed that the embolization coil was stuck inside the introducer sheath friction lock and was detached from the pusher assembly.These damages were likely incidental to the reported 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: 8364633
• Report Number: 3005168196-2019-00352
• Device Sequence Number: 16642959
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 01/25/2019
• 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: 05/17/2025
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F77230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005