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	05/24/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using a ruby coil detachment handle (handle) and ruby coils.During the procedure, the physician attempted to detach the ruby coil using the handle and an unusual sound was heard coming from the handle.The physician withdrew the ruby coil pusher assembly and realized the coil did not detach.Therefore, the ruby coil was re-advanced into the target location and the physician attempted to detach the coil using the handle three times without success.Therefore, the handle was removed and was no longer used in the procedure.The procedure was completed using another handle to detach the same ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle revealed that the nosecone was damaged.If the proximal end of the pusher assembly is forcefully inserted into the nosecone of the handle, damage such as this may occur.The nosecone to the handle was measured with calibrated pin gauges and was found to be out of specification.Therefore, the handle was unable to be functionally tested.Based on the returned condition, the root cause of the reported complaint could not be determined.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the inability to detach the ruby coil using the ruby coil detachment handle h3 other text : placeholder.

• 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: 12054510
• Report Number: 3005168196-2021-01404
• Device Sequence Number: 4304423
• 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): 07/29/2021
• 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: 09/10/2023
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F100139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005