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

Model Number	RBY4C2060-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
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 in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, prior to use, the hospital staff noticed that a ruby coil was detached from its pusher assembly and the embolization coil fell out of the packaging.The damaged ruby coil was found prior to use, and therefore, it was not used in the procedure.The procedure then continued with a new ruby coil.While advancing the new ruby coil through the lantern, the ruby coil became stuck; therefore, the lantern and ruby coil were removed together and the ruby coil was removed from the lantern.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 intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 31.0 cm, 98.0 cm and 118.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds at its proximal end.Conclusions: evaluation of the ruby coil revealed offset coil winds on the proximal end of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The lantern used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.During functional testing, the returned ruby coil was able to be advanced through its introducer sheath and a demonstration lantern with resistance due to the kinks on the pusher assembly.These pusher assembly kinks were likely incidental and could have occurred during packaging for return to penumbra.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: 9850074
• Report Number: 3005168196-2020-00385
• Device Sequence Number: 765259
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• 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): 02/24/2020
• 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 Model Number: RBY4C2060-A
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F92781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 65
• Date Report Sent to FDA: 01/01/2005