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

Model Number	RH1-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
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: 3005168196-2021-02716.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil, pod coils, pod packing coils (pod pcs), a ruby coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician placed a ruby coil, and six pod coils into the target vessel using a microcatheter.The physician then advanced a pod pc into the target vessel using the microcatheter and used a handle to detach it.However, the pod pc failed to detach after several attempted were made.It was reported that the physician manually checked the separator on the black alignment zone, but the delivery wire could not be pulled out from the handle.Subsequently, the pod pc unintentionally detached inside the microcatheter when pulling on the delivery wire.Therefore, the microcatheter containing the detached pod pc was removed and the pod pc was flushed out on the back table.The procedure was completed using six pod pcs and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle and pod pc pusher assembly confirmed that the pod pc¿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 pod pc without an issue.Evaluation of the pod pc pusher assembly revealed bends along its length, the pusher assembly was fractured, and blood was present within the ddt.This damage was likely incidental to the reported complaint.Due to the damage on the pod pc, the root cause of the reported detachment issues during the procedure could not be determined.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: 3005168196-2021-02716.

• 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: 12901952
• Report Number: 3005168196-2021-02715
• Device Sequence Number: 4828205
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022
• 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: 06/07/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F106887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005