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

Catalog Number	RBY2C1240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
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: 3005168196-2022-00337.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.A non-penumbra microcatheter, and a non-penumbra sheath.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a ruby coil through the microcatheter.While advancing the ruby coil into the target location, the physician was not satisfied with the way the ruby coil was forming in the vessel; therefore, the physician decided to remove the ruby coil.While retracting the ruby coil, it unintentionally detached with part of the coil inside the microcatheter and part in the vessel.Therefore, the physician removed the ruby coil with a syringe and aspiration.Next, the physician placed multiple coils successfully.The physician advanced another ruby coil into the microcatheter, however, resistance was met and the ruby coil became stuck near the hub of the catheter.While retracting the coil, it unintentionally detached within the microcatheter.Therefore, the ruby coil and microcatheter were removed together.The procedure was completed with new ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15023575
• Report Number: 3005168196-2022-00336
• Device Sequence Number: 2368374
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 814548013015
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2022
• 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: 06/11/2025
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F77628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 06/22/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005