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

Model Number	RBY2C0312-A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils, a ruby coil detachment handle (handle), a non-penumbra microcatheter and a diagnostic catheter.During the procedure, the physician advanced a ruby coil into the target vessel using the microcatheter, and used the handle to detach the ruby coil.It was reported that the black alignment zone (pet lock) on the ruby coil pusher assembly was separated, indicating a successful detachment.However, after detachment, the ruby coil was not visible in the target vessel under fluoroscopy, despite not having pulled back the ruby coil pusher assembly yet, but possibly only by approximately one centimeter.Therefore, the physician removed and flushed the microcatheter to see if the detached ruby coil was in the microcatheter, but the ruby coil was not in the microcatheter.The physician then removed and flushed the diagnostic catheter.It was noticed at that point that the detached ruby coil was inside the diagnostic catheter.The procedure was completed using additional ruby coils, the same handle, microcatheter, and diagnostic catheter.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: 9722906
• Report Number: 3005168196-2020-00205
• Device Sequence Number: 11568336
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/23/2020
• 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: 07/05/2025
• Device Model Number: RBY2C0312-A
• Device Catalogue Number: RBY2C0312
• Device Lot Number: C08796
• 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: 01/23/2020
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005