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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2017
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 numbers: 3005168196-2017-01525, 3005168196-2017-01526, the hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.Prior to the procedure, the vessel size was measured on the ct scan and an 8x40 centimeter (cm) ruby coil was selected for the procedure.During the procedure, the physician attempted to deploy the 8x40 cm ruby coil (lot #f75936) into the target vessel but realized that the coil was too large.Upon removing the ruby coil, the technologist inadvertently bent/kinked the ruby coil pusher assembly.The physician continued the procedure by successfully deploying and detaching four new ruby coils.While preparing two additional ruby coils (lot #f72625 and lot #f75368) for the procedure, the scrub technologist inadvertently kinked both pusher assemblies.Therefore, the ruby coils were not used for the procedure.The procedure was successfully completed using two new ruby coils.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: 6850316
• Report Number: 3005168196-2017-01524
• Device Sequence Number: 13467922
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/11/2017

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: Radiologic Technologist
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F72625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1