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

Model Number	RH1-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02671.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery using a ruby coil detachment handle (handle), ruby coils, and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil into the target location and attempted to detach it using the handle.Subsequently, the physician noticed that the ruby coil pusher wire was stuck inside the handle.However, the physician was able to manually detach the ruby coil and successfully implant it into the target location.At this point, the procedure was finished.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle and ruby coil confirmed that the ruby coil¿s pull tube was stuck inside the handle.If the proximal end of the pusher assembly is forcefully advanced into the handle, or if the handle is repeatedly actuated, damage such as this may occur.The handle was dis-assembled, and the pull tube was able to be removed.Subsequently, the handle was re-assembled and performed within specification when tested on a handle test fixture.The handle was used to detach a demonstration ruby coil without an issue.No damage was observed on the ruby coil other than the damage from the detachment attempts during the procedure.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.Penumbra coils are 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: 3005168196-2021-02671.

• 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: 12863040
• Report Number: 3005168196-2021-02672
• Device Sequence Number: 1520825
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021
• 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: 07/19/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F107838
• Was Device Available for Evaluation?: Yes
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Date Report Sent to FDA: 01/01/2005