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

Model Number	RH1-A
Medical Device Problem Codes	Mechanical Problem (1384); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned handle revealed that the proximal end of the returned ruby coil pusher assembly was stuck inside the handle.If the handle is actuated multiple times while attempting to detach the embolization coil from its pusher assembly, damage such as this may occur.Based on the returned condition, the cause of the reported detachment issue could not be determined.During the functional test, while attempting to remove the proximal end of the pusher assembly from the handle, the tab that holds on the nosecone was damaged.Therefore, no further functional testing could be performed.Evaluation of the returned ruby coil pusher assembly revealed that the pet lock was broken and stuck inside the returned handle, and the embolization coil was detached from its pusher assembly and was not returned for evaluation.Based on the returned condition, the root cause of the reported detachment issue could not be determined.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2021-02335.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil detachment handle (handle) and ruby coils.During the procedure, the physician advanced a ruby coil into the target vessel and attempted to detach it using a handle; however, the ruby coil failed to detach.Therefore, the physician manually detached the ruby coil.The procedure was completed using eight ruby coils and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2021-02334 1.Section h.Box 6.Device code 1.This report is associated with mfr report number: 3005168196-2021-02335.

• 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: 12661732
• Report Number: 3005168196-2021-02334
• Device Sequence Number: 4212155
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022
• 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 Expiration Date: 06/13/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F107054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005