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

Catalog Number	RBY4C0305
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2017
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.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type two endoleak using ruby coils.During the procedure, the physician deployed and detached the initial coils in the target vessel using a lantern delivery microcatheter (lantern) and a 5f non-penumbra catheter.While attempting to deploy the last ruby coil into the target vessel, the lantern was inadvertently pulled back into the 5f catheter.Consequently, when the ruby coil was advanced out of the lantern, it became lodged into the 5f catheter and would not move forward or backward.Therefore, the physician removed the system all together as one unit and the procedure was ended.It was reported that there was no noted damage to the ruby coil and lantern after removal.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: 6836788
• Report Number: 3005168196-2017-01463
• Device Sequence Number: 16157868
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• 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): 08/03/2017

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: 02/03/2024
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F67739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/31/2017
• 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