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

Catalog Number	RBY2C0612-A
Medical Device Problem Codes	Bent (1059); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was bent in multiple locations.The embolization coil was intact with the pusher assembly evaluation of the returned device revealed the pusher assembly was bent.This damage likely occurred due to forceful manipulation of the ruby coil during insertion into a microcatheter.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
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while advancing a ruby coil through another manufacturer¿s microcatheter, resistance was not encountered; however, the technologist inadvertently bent the ruby coil pusher assembly.Therefore, the ruby coil was removed and the procedure was completed using a new ruby coil and the same microcatheter.It should be noted that a rotating hemostasis valve (rhv) and a flush bag were not used during the procedure.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: 5889824
• Report Number: 3005168196-2016-01208
• Device Sequence Number: 1077155
• Product Code: HCG
• UDI-Device Identifier: 00814548012926
• UDI-Public: 00814548012926
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2016

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: 01/31/2021
• Device Catalogue Number: RBY2C0612-A
• Device Lot Number: F35968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2016
• Initial Report FDA Received Date: 08/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR