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

Model Number	RBY2C1240-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
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 internal iliac artery (iia) using a ruby coil.During the procedure, the ruby coil would not advance at all within its introducer sheath; therefore, it was removed.The physician then removed the ruby coil from its introducer sheath on the back table and noticed that the ruby coil was kinked.The procedure was completed using other 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 17.0 cm from the proximal end.The pusher assembly distal detachment tip (ddt) was fractured off the pusher assembly distal tip.The embolization coil was detached from the pusher assembly and had offset coil winds throughout its length.The distal tip of the embolization coil was advanced out of the introducer sheath.Coagulated blood was within the introducer sheath distal tip.Conclusions: evaluation of the returned ruby coil revealed that the ddt was fractured off the pusher assembly distal tip and the embolization coil was detached from the pusher assembly.The embolization coil had offset coil winds throughout its length and was partially advanced out of the introducer sheath.If the introducer sheath is not aligned properly within the hub of a parent device prior to advancement, resistance may be experienced and damage such as offset coil winds may occur.If the device is subsequently retracted against resistance, damage such as a fractured pusher assembly and detached embolization coil may occur.Further evaluation revealed coagulated blood within the introducer sheath and a pusher assembly kink.This damage was 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.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: 10026512
• Report Number: 3005168196-2020-00614
• Device Sequence Number: 11466465
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 04/17/2020
• 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: RBY2C1240-A
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F92776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 09/19/2020
• 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