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

Catalog Number	RBY4C0406
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the ruby coils pusher assembly was kinked in multiple locations.This type of damage typically occurs due to improper handling during removal from the packaging hoop.If the device is forcefully retracted out of its packaging hoop at extreme angles, damage such as this may occur.It is likely that the ruby coil sustained damage after the device was removed from its packaging hoop.Based on the returned condition of the ruby coil, it is unlikely that the ruby coil was packaged in this condition.Penumbra coils are visually 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, the scrub technologist noticed that a ruby coil was bent in multiple places upon removal from the dispenser hoop.It was noted that the ruby coil was bent in the package.The damaged ruby coil was found prior to use and therefore, was not use for the procedure.The procedure was completed using a new ruby coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6895462
• Report Number: 3005168196-2017-01674
• Device Sequence Number: 108828
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Radiologic Technologist
• Device Expiration Date: 12/19/2024
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F73284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• 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