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

Catalog Number	RBY2C0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 129.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Resistance was instantly encountered while attempting to advance the kinked pusher assembly through its introducer sheath and the ruby coil could not be advanced any further.Conclusions: evaluation of the returned ruby coil revealed that the pusher assembly was kinked.This kink was likely a result of attempting to advance the device against the reported resistance.This damage was not mentioned in the complaint description.During functional testing, the ruby coil was unable to be advanced through its sheath.The introducer sheath was stuck between the friction lock and the kink.Penumbra coils and catheters 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.
Event or Problem Description
While preparing a ruby coil on the back table for a coil embolization procedure, the ruby coil would not advance out of its introducer sheath; therefore, it was not used in the procedure.The procedure was completed using another ruby coil and a lantern delivery microcatheter (lantern).

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7687699
• Report Number: 3005168196-2018-01370
• Device Sequence Number: 11112139
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/15/2018
• 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: 12/25/2024
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F73376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• 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