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

Catalog Number	RBY2C0520-A
Medical Device Problem Codes	Bent (1059); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2016
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: 3005168196-2016-01162.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a renal arteriovenous malformation (avm) using pod4 coils and ruby coils.During the procedure, while deploying a pod4 coil, the physician was not satisfied with the way the coil was forming inside the target vessel and decided to remove the coil.The physician then changed the support catheter to better support the other manufacturer's microcatheter.While attempting to re-advance the pod4 coil into the other manufacturer's microcatheter, the physician encountered resistance and was unable to advance the coil into the microcatheter.Therefore, the pod4 coil was removed and a new ruby coil was opened to continue the procedure.While deploying this ruby coil, the physician was not satisfied with the way the coil was forming inside the target vessel and decided to remove it.As the ruby coil was being retracted from the patient, there was no report of resistance; however, the ruby coil pusher assembly became bent.The procedure was then completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5867177
• Report Number: 3005168196-2016-01163
• Device Sequence Number: 774145
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/13/2016

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: Physician
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: RBY2C0520-A
• Device Lot Number: F61753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 104