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	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01910.3005168196-2021-01911.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil detachment handle (handle), pod coils, a non-penumbra microcatheter, a non-penumbra catheter, and a non-penumbra guide catheter.During the procedure, the physician advanced a pod coil into the target location and attempted to detach it using a handle; however, the pod coil failed to detach after multiple attempts.It was reported that the coil alignment zone separated, but the pod coil did not detach.Therefore, the physician pulled the pusher assembly of the pod coil with the handle to detach it.It was also reported that the physician experienced resistance while inserting the proximal end of the pusher assembly into the handle.Next, the physician advanced another pod coil to the target location and attempted to detach it using the handle; however, the same issue occurred.Therefore, the physician also pulled the pusher assembly of the pod coil with the handle to detach it.The procedure was completed using another handle and eight additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle revealed that the nosecone funnel was damaged.If the proximal end of the pod coil pusher assembly is forcefully inserted into the handle, damage such as this may occur.If the nosecone funnel is damaged, the handle may not function properly.During functional testing, the handle was tested with a handle test fixture and performed within specification.A demonstration pod coil was able to be detached with the returned handle without an issue and then the proximal end of the pod coil pusher assembly was removed from the handle nosecone without issue.Penumbra handles are visually inspected and functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up: 1.Section g.Box 3.Report source.This report is associated with mfr report number: 1.3005168196-2021-01910, 2.3005168196-2021-01911.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 3005168196-2021-01909 1.Section h.Box 6.Device code 1 this report is associated with mfr report number: 1.3005168196-2021-01910 2.3005168196-2021-01911.

• 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: 12411370
• Report Number: 3005168196-2021-01909
• Device Sequence Number: 5304500
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023
• 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: 03/30/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F105024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 01/14/2005
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/17/2021; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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