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

Catalog Number	RBY4C0630
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
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 in the inferior mesenteric artery (ima) using ruby coils.During the procedure, the physician successfully implanted a ruby coil and a podj into the target vessel using a non-penumbra microcatheter.Upon advancement of another ruby coil, the physician experienced resistance.Subsequently, the ruby coil became stuck approximately 10 cm into the microcatheter.The physician then retracted the ruby coil, flushed the microcatheter, and made another attempt to advance.However, the physician experienced resistance while re-advancing the ruby coil and reported that the ruby coil became stuck in the same location.The ruby coil was therefore removed and was no longer used in the procedure.The procedure was completed using a new ruby coil and a lantern delivery microcatheter (lantern).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends were present on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The embolization coil was undamaged.Coagulated blood was found within the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed a functional device.During functional testing, the ruby coil was able to advance out of its introducer sheath with resistance caused by coagulated blood within the introducer sheath.The ruby coil was then advanced through a demonstration microcatheter without an issue.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the inability to advance the ruby coil could not be determined.Further evaluation revealed pusher assembly bends.These bends were 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.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: 8734692
• Report Number: 3005168196-2019-01232
• Device Sequence Number: 11330533
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 05/28/2019
• 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 Catalogue Number: RBY4C0630
• Device Lot Number: F87832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005