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

Catalog Number	RBY4C0202
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	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked in multiple locations along its length.The introducer sheath was twisted at its distal region that contained coagulated blood.During functional analysis, the penumbra investigator attempted to advance the ruby coil out of the introducer sheath, but met resistance when the coil reached the twist in the sheath.The distal region of the introducer sheath was then cut and the ruby coil could be advanced out of the sheath.The ruby coil was advanced out of a demo px slim delivery microcatheter (px slim) but resistance was encountered when attempting to retract the introducer sheath proximal to the most proximal kink on the pusher assembly.Conclusions: evaluation of the returned device revealed that the introducer sheath was twisted.During functional analysis, it was determined that this damage contributed to the resistance and inability to advance the ruby coil out of the introducer sheath.Further evaluation revealed that the pusher assembly was kinked in multiple locations.This damage can occur if the coil is forcefully advanced against resistance.During functional analysis, the ruby coil was able to be advanced through a demonstration px slim without issue.Since the non-penumbra microcatheter used in the complaint was not returned, the root cause of the reported inability to advance the coil during the procedure could not be determined.The microcatheter mentioned in the complaint was not returned for evaluation.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.
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 a microcatheter, the physician experienced resistance and was unable to advance the coil.Therefore, the ruby coil was removed.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.Please note that the manufacturer has made at least three attempts to obtain patient information and additional information regarding the procedure; however, the customer was unable to provide the information.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6818820
• Report Number: 3005168196-2017-01432
• Device Sequence Number: 10797487
• Product Code: HCG
• UDI-Device Identifier: 00814548013121
• UDI-Public: 00814548013121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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: 01/03/2025
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F73501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1