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

Catalog Number	RBY2C1857
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
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: 3005168196-2019-00685.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician advanced the first ruby coil into the target vessel and reported that it was unable to detach using the handle.The physician then attempted to manually detach the ruby coil but was unable to.The ruby coil was then removed and was no longer used in the procedure.The physician then used six additional ruby coils and the same handle to complete the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the ruby coil pusher assembly.The pusher assembly was fractured in multiple locations along its length.The embolization coil was intact with its fractured pusher assembly.During functional testing, the pull wire was retracted out of the fractured pusher assembly by the penumbra investigator and the embolization coil was able to detached from its pusher assembly without issue.Conclusions: evaluation of the returned ruby coil revealed that the pet lock was broken, the pusher assembly was fractured, and the embolization coil remained intact with its pusher assembly.If the handle was attached to the proximal end of the pusher assembly and actuated, the pet lock will likely separate on the proximal end of the pusher assembly.Further evaluation revealed the embolization coil was intact with the returned pusher assembly.If the pull wire is not retracted out of the distal detachment tip (ddt), the embolization coil will remain intact with its pusher assembly.The cause of the reported detachment issue could not be determined.Further evaluation of the ruby coil revealed that the pusher assembly was fractured in multiple locations.The complaint reported that the ruby coil was able to be removed from the patient and did not mention fracturing of the device.Therefore, the fractures are likely incidental to the complaint.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.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the detachment issue.This report is associated with mfr report number: 3005168196-2019-00685.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8508559
• Report Number: 3005168196-2019-00684
• Device Sequence Number: 1664142
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 03/14/2019
• 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: 04/22/2026
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F82992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005