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

Catalog Number	RBY2C1260
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils, during the procedure, while advancing a ruby coil through a non-penumbra microcatheter, it became stuck.Therefore, the ruby coil was removed.The procedure was completed using new ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra sales representative on may 01, 2019.Box 5.Describe event or problem.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 10.5 cm and 15.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.Conclusions: evaluation of the returned ruby coil revealed offset coil winds.This type of damage typically occurs when advancing the device against resistance.This damage may have contributed to the reported device becoming stuck within the non-penumbra microcatheter.During functional testing, the ruby coil was advanced through a demonstration microcatheter without issue.The non-penumbra microcatheter was not returned for evaluation, therefore, the root cause of the reported complaint could not be determined.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.Box 6.Conclusions code 1: (b)(4)¿ the investigation findings do not lead to a clear conclusion about the cause of not able to advance.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils.During the procedure, the physician successfully placed ruby coils in the target vessel using a non-penumbra microcatheter.The physician then was unable to advance a new ruby coil through the microcatheter.Consequently, the ruby coil became stuck inside of the microcatheter and, therefore, it was removed.The procedure was completed using new ruby coils with 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: 8489195
• Report Number: 3005168196-2019-00649
• Device Sequence Number: 14049363
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• 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): 03/07/2019
• 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: 09/04/2026
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F85717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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