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

Model Number	RBY4C0315-B
Medical Device Problem Codes	Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils, a penumbra coil detachment handle (handle), a lantern delivery microcatheter (lantern), and a guidewire.During the procedure, the physician successfully implanted three non-penumbra coils and used the handle to implant two penumbra smart coils (smart coils) and two pod coils.After advancing a ruby coil into the target location, the physician attempted to detach it with the handle; however, the ruby coil did not detach.Subsequently, the ruby coil unintentionally detached inside the lantern.While using the guidewire to push the ruby coil into the target location, the physician experienced resistance; however, the ruby coil was successfully implanted.Subsequently, imaging revealed that the guidewire had perforated the lantern.Therefore, the lantern and the guidewire were removed.An angiography showed that the target vessel was sufficiently embolized; therefore, the procedure ended at this point.There was no report of an adverse effect to the patient.
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2022-00062.

• 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: 13551016
• Report Number: 3005168196-2022-00061
• Device Sequence Number: 17460217
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022
• 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: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• 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: 01/21/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005