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

Model Number	RBY2C2860-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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: 3005168196-2021-00782.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery using a lantern delivery microcatheter (lantern) and guidewire.It was reported the patient¿s anatomy was highly tortuous.During the procedure, the physician implanted seven ruby coils in the target location.When the next ruby coil was retracted from the aneurysm for reforming, the ruby coil unintentionally detached in the lantern.The physician then retrieved the detached ruby coil and lantern.Subsequently, the physician reinserted the same lantern.When advancing the lantern along the guidewire, the physician encountered resistance.Therefore, the lantern was retrieved again.The physician resumed the procedure with a new lantern.No additional coils were implanted.It was determined the embolization had been completed when the confirmation contrast was performed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2021-00781.Section h.Box 3.Report source.This report is associated with mfr report number: 3005168196-2021-00782.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11689110
• Report Number: 3005168196-2021-00781
• Device Sequence Number: 11545383
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 00814548019314
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021
• 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 Model Number: RBY2C2860-B
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F91859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005