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

Model Number	RBY4C0835-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
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: 3005168196-2020-00159.
Event or Problem Description
The patient was undergoing a coil embolization in the splenic artery to treat an aneurysm using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed two ruby coils in the aneurysm sac using the lantern.While advancing the next ruby coil through the lantern and a few centimeters into the aneurysm sac, the physician experienced resistance and immediately stopped pushing the ruby coil forward.While attempting to withdraw the ruby coil, the physician noticed that the ruby coil had unintentionally detached.Therefore, the physician attempted to use a snare device to remove the detached ruby coil, but it was unsuccessful.The physician then decided to secure the detached ruby coil to the vessel wall by placing a self-expanding stent.The procedure ended at this point.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
• MDR Report Key: 9712908
• Report Number: 3005168196-2020-00158
• Device Sequence Number: 16744420
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/16/2020
• 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 Expiration Date: 06/24/2026
• Device Model Number: RBY4C0835-A
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F84309
• 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: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005