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

Model Number	RH1-A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
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 right coronary and circumflex fistula using ruby coils, a ruby coil detachment handle (handle), pod coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed and detached a pod coil in the target vessel using the handle.Subsequently, the physician detached a ruby coil using the handle; however, the pusher assembly of a ruby coil was stuck inside the handle after the physician had successfully detached the ruby coil.Therefore, the handle was not used for the remainder of the procedure.The procedure was completed using a new handle, a pod coil, and a pod packing coil (pod pc).There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• 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: 12849369
• Report Number: 3005168196-2021-02643
• Device Sequence Number: 17231184
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 11/19/2021
• 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 Expiration Date: 06/07/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F106878
• 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: 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005