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

Catalog Number	RBY2C1035
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 right common iliac artery using ruby coils.During the procedure, the physician successfully placed two ruby coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a ruby coil through the microcatheter, despite repositioning the microcatheter.Therefore, the physician retracted the coil.However, while retracting, the ruby coil unintentionally detached.The physician then removed the microcatheter with the ruby coil inside and flushed the coil out.The procedure was then completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the embolization coil was returned detached from its pusher assembly and the proximal constraint sphere was present on the proximal end of the coil.The embolization coil had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly and the proximal constraint sphere was present on the proximal end of the coil.If device was forcefully retracted against resistance, the embolization coil may detach from its pusher assembly.The non-penumbra microcatheter and pusher assembly to the returned ruby coil were not returned for evaluation.Therefore, the root cause of the reported detachment issue could not be determined.Penumbra coils are visually 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.Conclusions code 1:  4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported detachment issue.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8556634
• Report Number: 3005168196-2019-00816
• Device Sequence Number: 2359087
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/28/2019
• 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 Expiration Date: 05/10/2025
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F77073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005