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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
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: 3005168196-2017-00377.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.During the procedure, while advancing a ruby coil through the non-penumbra microcatheter and into the target vessel, the physician did not mention any resistance.However, due to tortuous anatomy, the microcatheter backed out of the vessel.The physician then retracted and resheathed the ruby coil back into its introducer sheath in order to reposition the microcatheter.The physician mentioned that there was resistance while the coil was being retracted.When attempting to re-deploy the ruby coil, the physician had difficulty advancing the ruby coil out of its introducer sheath.Consequently, upon applying force, the ruby coil pusher assembly became kinked.Therefore, the ruby coil was not re-deployed and a new ruby coil was opened.However, the same issue occurred and ruby coil was resheathed in order to reposition the microcatheter.While attempting to resheath the ruby coil, the physician mentioned that there was resistance and subsequently, the coil unintentionally detached before the coil could be fully resheathed.The ruby coil was already out of the patient's body and out of the microcatheter.The procedure was then completed using the same non-penumbra microcatheter and an additional coil.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: 6414597
• Report Number: 3005168196-2017-00378
• Device Sequence Number: 650369
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

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: Physician
• Device Expiration Date: 12/03/2024
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F72984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/17/2017
• 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