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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked approximately 5.0 cm from the proximal end.Conclusions: evaluation of the returned device confirmed that it was kinked near its proximal end.This damage likely occurred due forceful handling during removal from the packaging.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
During preparation for a coil embolization procedure, the radiologic technologist inadvertently kinked a ruby coil pusher assembly while removing the ruby coil from its dispenser hoop.The pusher assembly became kinked prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using new ruby coils.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6938635
• Report Number: 3005168196-2017-01716
• Device Sequence Number: 19142215
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2017

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: 11/21/2024
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F72211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1