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

Catalog Number	RBY4C0305
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-01675.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization in the left gastric artery procedure using ruby coils.During the procedure, the physician felt resistance and was unable to advance a ruby coil fully out of the non-penumbra microcatheter and into the vessel, despite multiple attempts to re-position the ruby coil; therefore, the ruby coil was removed.The physician then was unable to advance a second ruby coil out of the microcatheter at all, despite multiple attempts; therefore, the ruby coil was removed.The procedure was completed using additional coils, the same microcatheter, and gel foam was delivered to embolize the vessel.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6895477
• Report Number: 3005168196-2017-01676
• Device Sequence Number: 10920874
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/05/2017

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: 05/28/2025
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F77366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR