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

Model Number	RBY2C0630-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil revealed offset coil winds and pusher assembly kinks.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed pusher assembly bends and the ruby coil was returned with an unoriginal introducer sheath and the sheath was ovalized.This damage was likely incidental to the reported complaint.During functional testing, the ruby coil was advanced through the introducer sheath without an issue.The ruby coil was advanced through the returned non-penumbra microcatheter without an issue.Evaluation of the second returned ruby coil revealed that the embolization coil was detached from its pusher assembly and was returned within a non-penumbra microcatheter.Further evaluation of the embolization coil revealed offset coil winds along its length and the proximal constraint sphere was not present.Further evaluation of the non-penumbra microcatheter revealed a kink on the distal shaft.The embolization coil was removed from the non-penumbra microcatheter with strong resistance and the sr wire was observed to be fractured.If the ruby coil is forcefully retracted against resistance, damage such as this may occur.The kink in the non-penumbra microcatheter may have contributed to resistance during the procedure.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.This report is associated with mfr report number: 3005168196-2021-00984.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a microcatheter.During the procedure, while the physician advanced a ruby coil halfway through the microcatheter, the ruby coil became stuck.Therefore, the ruby coil was removed.Afterwards, while the physician advanced a new ruby coil through the microcatheter, the same issue occurred.The ruby coil became stuck inside the microcatheter.Therefore, the ruby coil and microcatheter were removed together.The procedure was completed using a new ruby coil.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: 11795223
• Report Number: 3005168196-2021-00985
• Device Sequence Number: 13708260
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2021
• 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: 10/15/2021
• Device Model Number: RBY2C0630-A
• Device Catalogue Number: RBY2C0630
• Device Lot Number: A39022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/08/2021
• 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