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

Model Number	RBY2C1857-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
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: 3005168196-2018-00329.
Event or Problem Description
The patient was undergoing a coil embolization in the unipolar iliacs using ruby coils and a px slim delivery microcatheter (px slim).It was noted that the patient's anatomy was not tortuous.During the procedure, the physician was unable to advance a ruby coil through the px slim.Therefore, the px slim and ruby coil were removed.The physician then placed a new px slim and attempted to re-advance the same ruby coil; however, the ruby coil would not advance.Subsequently, the ruby coil was removed and the procedure was completed using another ruby coil and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note correction to sections: date of this report: 1/16/2018.Pre-market identification: 1/16/2018.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was intact on the embolization coil.The embolization coil had some offset coil winds on its length.Conclusions: evaluation of the returned ruby coil revealed a detached embolization coil with some offset coil winds.The proximal constraint sphere was intact with the embolization coil.This would suggest the pull wire was retracted from the distal detachment tip (ddt) either via the pet lock breaking or pusher assembly fracturing post-procedure.The offset coil winds were likely incidental and possibly due to being aspirated into the returned syringe.The root cause of the reported difficulty advancing 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.The investigation findings do not lead to a clear conclusion about the root cause of the reported advancement issue through the px slim.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7262249
• Report Number: 3005168196-2018-00328
• Device Sequence Number: 11068320
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2018
• 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: Physician
• Device Expiration Date: 07/18/2025
• Device Model Number: RBY2C1857-A
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F78242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/16/2018; 07/18/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 05/14/2018; 09/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005