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

Model Number	RBY2C2860-A
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
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.This report is associated with mfr report number: 3005168196-2019-02454.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the celiac artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing the second ruby coil through the lantern, the ruby coil became stuck inside the lantern; therefore, it was removed and re-sheathed.The physician then attempted to advance the ruby coil out of its introducer sheath on the back table; however, the ruby coil detached from its pusher assembly.Therefore, the ruby coil was no longer used.The physician continued the procedure using two other ruby coils and the same lantern.While advancing the fifth ruby coil through the lantern, the ruby coil became stuck inside the lantern.The physician then retracted the ruby coil and attempted to re-sheath it back into its introducer sheath; however, ten centimeters could not be re-sheathed.Therefore, the ruby coil was not used.The procedure was completed using new ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was intact on the proximal end of the embolization coil.Offset coil winds were present along the length of the embolization coil.The introducer sheath was undamaged.Conclusions: evaluation of the first returned ruby coil confirmed a detached embolization coil and revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The pusher assembly associated with the ruby coil was not returned for evaluation; therefore, the root cause of the embolization coil detaching could not be determined.The introducer sheath was undamaged.Evaluation of the second returned ruby coil revealed offset coil winds along the length of the embolization coil and that the ruby coil was returned with the embolization coil partially out of the introducer sheath.If the device is forcefully advanced against resistance, damage such as offset coils winds may occur.Subsequently, re-sheathing a damaged coil may also contribute to additional offset coil winds.The ruby coil was unable to be retracted into or advanced through its introducer sheath due to coagulated blood within the introducer sheath and the offset coil winds.The lantern identified in the complaint was not returned for evaluation; therefore, the root cause of resistance experienced while advancing both returned ruby coils during the procedure 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.This report is associated with mfr report number: 1.3005168196-2019-02454.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9537091
• Report Number: 3005168196-2019-02453
• Device Sequence Number: 14353303
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• 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): 12/11/2019
• 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: 06/19/2025
• Device Model Number: RBY2C2860-A
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F77812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 03/07/2020
• 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