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

Model Number	RBY2C1260-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
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: 3005168196-2020-01892.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed a ruby coil into the aneurysm; however, the physician was not satisfied with the placement of the ruby coil.While retracting the ruby coil to reposition it, the physician experienced resistance and subsequently, the ruby coil became stuck within the lantern.Therefore, the physician removed all devices from the patient and then removed the ruby coil from the lantern.The physician then placed two ruby coils into the aneurysm using the lantern.While implanting the last ruby coil (f93620) inside the aneurysm, the ruby coil unintentionally detached and subsequently, part of the ruby coil was in the renal artery.Therefore, the physician placed a stent to hold part of the ruby coil within the vessel wall.The procedure ended at this point.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil through the lantern, the operator kinked the ruby coil.Subsequently, the lantern and ruby coil were removed from the patient.The ruby coil was removed from the lantern and the microcatheter was re-introduced into the patient.Then, the physician placed a ruby coil into the aneurysm; however, the physician was not satisfied with the placement of the ruby coil.While retracting the ruby coil to reposition it, the physician experienced resistance and the ruby coil became stuck within the lantern.Therefore, the physician removed all devices from the patient and then removed the ruby coil from the lantern.The physician then placed two ruby coils into the aneurysm using the lantern.While implanting the last ruby coil (f93620) inside the aneurysm, the ruby coil unintentionally detached and subsequently, part of the ruby coil was in the renal artery.Therefore, the physician placed a stent to hold part of the ruby coil within the vessel wall.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 11/25/2020: section b.Box 5.Describe event or problem.This report is associated with mfr report numbers: 3005168196-2020-01892; 3005168196-2020-02353.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10792316
• Report Number: 3005168196-2020-01891
• Device Sequence Number: 3694276
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C1260-A
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F93620
• 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: 10/06/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005