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

Model Number	RBYLP0315
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2021-02240.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak using ruby coil lps, a lp system detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, while advancing a ruby coil lp into the target location using the microcatheter, the physician experienced resistance.Subsequently, the physician attempted to detach the ruby coil lp using the handle; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.Afterwards, while advancing the next ruby coil lp into the target location using the microcatheter, the same issue occurred.The physician experienced resistance and subsequently, the ruby coil lp failed to detach using the handle.Therefore, the ruby coil lp was also removed.The procedure was completed using two new ruby coil lps, the same handle, and a new lantern delivery microcatheter (lantern).There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12602671
• Report Number: 3005168196-2021-02239
• Device Sequence Number: 3269852
• Product Code: HCG
• UDI-Device Identifier: 00815948021792
• UDI-Public: 00815948021792
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/10/2021
• 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: 06/08/2026
• Device Model Number: RBYLP0315
• Device Catalogue Number: RBYLP0315
• Device Lot Number: F106972
• Was Device Available for Evaluation?: No
• 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: 09/14/2021
• Initial Report FDA Received Date: 10/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Date Report Sent to FDA: 01/01/2005