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

Catalog Number	RBY2C0725
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
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.This report is associated with mfr report number: 3005168196-2019-01324, 3005168196-2019-01328.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully placed six ruby coils in the target vessel using a non-penumbra microcatheter.During the detachment of the seventh coil, after pulling the trigger, one of the two black lines on the back of the pusher wire was missing and the coil was still attached, therefore, the ruby coil and the handle were removed.A new handle was used with the same ruby coil and upon detachment of the ruby coil the pusher assembly got stuck in the handle but the ruby coil was successfully detached.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 39.5cm from the proximal end of its pusher assembly.The pull wire was retracted out of its distal detachment tip (ddt) and the embolization coil was detached from its pusher assembly.The ddt had coagulated blood inside.Conclusions: evaluation of the returned handle revealed that the device was functional.The handle was functionally tested on a handle test fixture and performed within specification.The root cause of the failure to detach during the procedure could not be determined.The handle was opened by the penumbra investigator and the proximal end of the separated pet lock was present.Evaluation of the returned ruby coil pusher assembly revealed that the pet lock was separated, and coagulated blood was within the ddt.If the pet lock is separated and the pull wire is completely retracted out of the ddt, the embolization coil will detach from its pusher assembly.However, if the ddt is occluded prior to a detachment attempt using the handle is made, it may prevent the embolization coil from detaching.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.The kink was likely incidental to the reported complaint and may have occurred from packaging the device for return to penumbra.The embolization coil was implanted, and the second handle identified in the complaint was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected during incoming inspection and functionally tested by quality.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: (b)(4).(b)(4).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: 8776984
• Report Number: 3005168196-2019-01327
• Device Sequence Number: 1993389
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019
• 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: 06/30/2022
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F43888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005