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

Catalog Number	RBY2C0512
Medical Device Problem Codes	Failure to Fold (1255); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
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: 3005168196-2019-00435.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a splenic artery bleed using ruby coils.During the procedure, while attempting to place a ruby coil into the target vessel using a non-penumbra microcatheter, the physician noticed the ruby coil would not take its intended shape and therefore the physician decided to remove the ruby coil.However, upon removal, the ruby coil detached outside of the patient¿s body.The physician then advanced a new ruby coil into the target vessel; however, the ruby coil was oversized, and the physician decided to retract it.While retracting the ruby coil, it unintentionally detached and became stuck inside of the microcatheter.Therefore, the microcatheter containing the ruby coil was removed.The procedure was completed using additional ruby coils and a new non-penumbra 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: 8405261
• Report Number: 3005168196-2019-00434
• Device Sequence Number: 297995
• Product Code: HCG
• UDI-Device Identifier: 00814548012896
• UDI-Public: 00814548012896
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/07/2019
• 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: Health Professional
• Device Expiration Date: 12/04/2025
• Device Catalogue Number: RBY2C0512
• Device Lot Number: F80874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005