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

Catalog Number	RBY4C1035
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
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 10.0 and 44.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first evaluated ruby coil revealed that the coil winds were offset.If the ruby coil is forcefully manipulated against resistance, damage such as this may occur.While advancing the returned ruby coil through a demonstration microcatheter, resistance was encountered as the offset coil winds bunched up inside the introducer sheath and the ruby coil could not be advanced any further.Further evaluation of the returned device revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return.Evaluation of the second ruby coil revealed that the introducer sheath was loaded backwards on the pusher assembly.If the introducer sheath is loaded backward prior to advancing the coil into a microcatheter, resistance may be encountered.While attempting to advance the returned ruby coil through a demonstration microcatheter, resistance was encountered as the mid-joint on the pusher assembly was being advanced through the introducer sheath friction lock and the ruby coil could not be advanced any further.The introducer sheath being loaded backward likely contributed to the ruby coil not being able to be advanced through the microcatheter.The non-penumbra microcatheter was not returned to penumbra for evaluation.Penumbra coils 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.This report is associated with mfr report number: 3005168196-2018-00912.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, two ruby coils would not advance into a non-penumbra microcatheter; therefore, they were removed.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7479826
• Report Number: 3005168196-2018-00911
• Device Sequence Number: 195955
• Product Code: HCG
• UDI-Device Identifier: 00814548013220
• UDI-Public: 00814548013220
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: Physician
• Device Expiration Date: 12/18/2024
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F73266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1