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

Model Number	RH1-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
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 numbers: 3005168196-2021-01883.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a ruby coil detachment handle (handle), pod packing coils (pod pcs), and a non-penumbra microcatheter.During the procedure, the physician made three attempts to detach the first pod pc with the handle without success.The pod pc was detached manually and the handle was no longer used in the procedure.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle could not confirm the reported compliant.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration pod pc without an 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.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12363202
• Report Number: 3005168196-2021-01882
• Device Sequence Number: 3822168
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021
• 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: 04/12/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F105334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005