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

Catalog Number	RBY2C0620
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
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 numbers: a 3005168196-2017-00676, 3005168196-2017-00678.The coil was inadvertently disposed by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization in the splenic artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the scrub technologist experienced resistance and the ruby coil kept getting stuck in the microcatheter.The scrub technologist believes that the very tortuous nature of the vessel was causing the microcatheter to cinch down on the ruby coil.Therefore, the ruby coil was removed.While attempting to advance two other ruby coils through the microcatheter, resistance was felt and subsequently, the ruby coils would not advance through the microcatheter; therefore, they were removed.It was reported that the scrub technologist inadvertently kinked both ruby coils after removing them from the packaging hoop.The procedure was completed using a lantern delivery microcatheter and two additional ruby coils.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: 6535710
• Report Number: 3005168196-2017-00677
• Device Sequence Number: 13711402
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/04/2017

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: 08/31/2024
• Device Catalogue Number: RBY2C0620
• Device Lot Number: F71447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR