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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2018
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 numbers: 3005168196-2018-00455.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a large varicocele using ruby coils and a pod5.During the procedure, prior to use, a ruby coil pusher assembly became kinked while being removed from the dispenser hoop; therefore it was set aside and the procedure continued with other coils.The physician then had difficulty advancing a pod5 into the existing coil mass in the varicocele due to the fact that the pod5 was the wrong size; therefore, it was removed.The procedure was successfully completed using other ruby coils and the same lantern delivery microcatheter (lantern).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: 7307933
• Report Number: 3005168196-2018-00454
• Device Sequence Number: 19168230
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• 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
• Report Date (Section B): 02/06/2018

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: 10/12/2024
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F72077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1