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

Catalog Number	RBY2C0620-A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2015
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 number: 3005168196-2016-00021.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the accessory branch for a fistula using ruby coils.During the procedure, while in use with a px slim delivery microcatheter (px slim) and another manufacturer's diagnostic catheter, the physician pulled back the px slim before the ruby coil was fully advanced out into the target vessel.Subsequently, the ruby coil became lodged in the diagnostic catheter and the entire system was removed from the patient.The physician then attempted to deploy a second ruby coil using the same px slim; however, the same incident occurred and the ruby coil became lodged in the diagnostic catheter.The physician removed the entire system and completed the procedure using another manufacturer's stent device.There were no reported issues with the px slim and 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: 5345760
• Report Number: 3005168196-2016-00020
• Device Sequence Number: 66614
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 12/10/2015

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: 06/30/2020
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F64247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR