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

Catalog Number	RBY2C0620
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
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: 3005168196-2016-01789.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to advance a ruby coil through another manufacturer¿s microcatheter, the physician experienced resistance and the ruby coil would not advance.Therefore, the ruby coil was removed.The physician then attempted to advance a new ruby coil through the same microcatheter; however, resistance was encountered again and the ruby coil would not advance.Therefore, it was removed.The procedure was then completed using another manufacturer¿s coils and the same microcatheter.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.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 ruby coil.The pusher assembly was kinked in multiple locations.The embolization coil¿s stretch resistant wire (sr wire) was fractured.The proximal constraint sphere was inside the distal detachment tip (ddt).Conclusions: evaluation of the first evaluated ruby coil revealed that the ruby coil was functional.During the functional analysis, the ruby coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.The outer diameter (od) of the embolization coil was measured and found to be within specification.Evaluation of the second ruby coil revealed that the embolization coil¿s stretch resistant (sr) wire was fractured.This type of damage likely occurred due to forceful retraction against resistance.Fracture of the sr wire will allow the embolization coil to detach from the pusher assembly.Further evaluation of the second ruby coil revealed that the pusher assembly was kinked in multiple locations.This type of damage likely occurred from forceful manipulation against resistance during use.Evaluation of the non-penumbra microcatheter revealed that the catheter was ovalized.The ovalization in the non-penumbra microcatheter likely contributed to the resistance that was experienced during the procedure while using both ruby coils.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6156933
• Report Number: 3005168196-2016-01790
• Device Sequence Number: 13633665
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/10/2016

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: 05/07/2024
• Device Catalogue Number: RBY2C0620
• Device Lot Number: F69245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 93