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

Model Number	RBY2C0410-B
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
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 inferior mesenteric artery (ima) using a ruby coil, a ruby coil detachment handle (handle), a non-penumbra microcatheter, a 5fr non-penumbra sheath, a 5fr non-penumbra guide catheter, and a non-penumbra guidewire.It was noted that the patient¿s anatomy was extremely tortuous.During the procedure, the physician advanced the sheath into the right groin, advanced the guide catheter through the sheath, and advanced the microcatheter to the target vessel through the guide catheter.The physician then flushed the ruby coil and microcatheter with saline on the back table.While re-attempting to advance the ruby coil to the target vessel using the microcatheter, the ruby coil became stuck and would not exit the microcatheter.The physician then removed the ruby coil and flushed the microcatheter again with saline.While attempting to re-advance the ruby coil, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using a non-penumbra coil and the same 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12920879
• Report Number: 3005168196-2021-02726
• Device Sequence Number: 5719078
• Product Code: HCG
• UDI-Device Identifier: 00814548018577
• UDI-Public: 00814548018577
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2021
• 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 Model Number: RBY2C0410-B
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F107190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 11/08/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005