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

Model Number	RBY4C0620-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
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 to treat an inferior pancreaticoduodenal artery (ipda) aneurysm using a ruby coil, a ruby coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced the ruby coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same handle.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.The pusher assembly was kinked at approximately 129.0 cm and 131.0 cm from its proximal end.The embolization coil was undamaged and intact with the pusher assembly.Coagulated blood was observed within the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed that the pet lock was intact on the proximal end of the pusher assembly and undamaged.If the handle is not properly seated on the pusher assembly prior to actuation, the pet lock may not separate.If the pet lock is not separated and the pull wire is not retracted from the distal detachment tip, the embolization coil may not detach from its pusher assembly.The handle used in the complaint was not returned for evaluation; therefore, the root cause of the complaint was unable to be determined.Further evaluation of the ruby coil revealed pusher assembly kinks.These kinks were likely incidental to the complaint and could have occurred during packaging for return to penumbra.During functional testing, the ruby coil was unable to be advanced through its introducer sheath due to the kinks.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: 9857820
• Report Number: 3005168196-2020-00410
• Device Sequence Number: 14310852
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: AS
• 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): 02/25/2020
• 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: 07/24/2026
• Device Model Number: RBY4C0620-A
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F84919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005