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

Catalog Number	RBY2C0930
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2019-00015.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician was unable to detach the ruby coil using the handle.The ruby coil and handle were therefore removed and were not used in the procedure.No further details were provided.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on (b)(6) 2019.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left renal artery using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed a ruby coil into the target vessel using a lantern delivery microcatheter (lantern).The physician then attempted to deploy a second ruby coil using the handle, but was unable to detach it after several attempts to do so.The ruby coil and handle were therefore removed.The procedure was completed using another ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated, the pull wire was fractured, the proximal pull tube was not returned.The pull wire was fractured approximately 5.5 cm from the proximal end of the returned device, approximately 1.5 cm proximal to a pusher assembly kink.The pusher assembly was kinked at approximately 7.0 cm and 14.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was not returned with the device.Conclusions: evaluation of the returned ruby coil revealed a pusher assembly kinks and a fractured pull wire on the proximal end of the device.If the device is mishandled or forcefully advanced, damage such as kinks may occur.Damage such as this may cause the pull wire to become pinned within the pusher assembly.If the pinned pull wire is then forcefully retracted, the pull wire may fracture and cause the pull wire to remain within the distal detachment tip.This would likely contribute to the reported inability to detach the embolization coil.The handle used in the procedure and the fractured portion of the pusher assembly pull wire were not returned for evaluation.Further investigation revealed offset coil winds along the embolization coil length.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8218474
• Report Number: 3005168196-2019-00014
• Device Sequence Number: 1670704
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): Y
• Initial Reporter Country: LG
• 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,Followup
• Report Date (Section B): 12/05/2018
• 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: 11/10/2022
• Device Catalogue Number: RBY2C0930
• Device Lot Number: C09753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/21/2019; 03/07/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/15/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005