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

Model Number	RBY2C1240-A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2017
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: 3005168196-2017-00915.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using ruby coils.During the procedure, the physician placed a non-penumbra diagnostic catheter in the target vessel, then advanced a lantern delivery microcatheter (lantern) through the diagnostic catheter.While deploying a ruby coil, the physician was not satisfied with the way the coil was forming inside the target vessel and decided to remove it for re-positioning.It was reported that the physician did not mention resistance while attempting to retract the ruby coil; however, the ruby coil unintentionally detached from its pusher assembly inside the lantern.Therefore, the physician removed the lantern containing the detached coil from the patient and used a wire to remove the coil from the lantern.The physician then reinserted the lantern into the patient¿s body.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and decided to retract the ruby coil; however, upon retraction, the ruby coil unintentionally detached within the microcatheter.Therefore, the physician removed the lantern containing the detached coil from the patient.The procedure was then completed using another microcatheter and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2017-00914.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6643322
• Report Number: 3005168196-2017-00914
• Device Sequence Number: 19071006
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017
• Report Date (Section F): 01/01/2005

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: 04/04/2024
• Device Model Number: RBY2C1240-A
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F68827
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005