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

Model Number	RBYLP0210
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps and a non-penumbra microcatheter.During the procedure, a ruby coil lp was kinked while loading into the micro-catheter.Therefore, the ruby coil lp was removed.The procedure was completed using new coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device was received on 4/21/2021 for this event.However, investigation revealed that the incorrect device was received instead of the device related to this complaint.Multiple attempts were made to obtain the actual complaint device from the hospital; however, were unsuccessful.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda).2.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy).3.Section h.Box 3: device returned to manufacturer? 4.Section h.Box 6: results code 1.5.Section h.Box 6: conclusions code 1.Additional information was added to: 1.Section h.Box 6.Method code 1 & method code 2.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11787275
• Report Number: 3005168196-2021-00975
• Device Sequence Number: 11674154
• Product Code: HCG
• UDI-Device Identifier: 00815948021761
• UDI-Public: 00815948021761
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021
• 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: 07/13/2025
• Device Model Number: RBYLP0210
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F98856
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005