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

Catalog Number	RBY2C0825
Medical Device Problem Codes	Positioning Failure (1158); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2017-02211.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil through the lantern and into the target vessel; however, the ruby coil would not take its intended shape.After the ruby coil was advanced and retracted several times, it unintentionally detached.The physician mentioned experiencing resistance while retracting the ruby coil within the lantern.A syringe was then placed on the back of the lantern for negative suction and both the lantern and detached ruby coil were pulled out of the patient.Thereafter, the procedure was successfully completed using additional coils and another microcatheter.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: 7110105
• Report Number: 3005168196-2017-02210
• Device Sequence Number: 1091876
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/16/2017

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: 08/02/2025
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F78494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 125