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

Catalog Number	RBY2C3260
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
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: 3005168196-2018-01491.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, prior to use, the hospital technician inadvertently kinked the ruby coil on the back table; therefore, it was not used in the procedure.While advancing a ruby coil in the aneurysm using a non-penumbra microcatheter, the hospital technologist pulled back the microcatheter and lost access to the aneurysm.Therefore, it was decided to retract the ruby coil; however, upon retracting a ruby coil out of the microcatheter, the ruby coil unintentionally detached.It was reported that half of the ruby coil was in the aneurysm and the other half in the native vessel (anterior tibial artery to superficial femoral artery).Therefore, the physician decided to snare the detached coil; however, the ruby coil broke in half.The physician was able to use forceps to remove the remaining coil.The procedure was completed using additional ruby coils and the same microcatheter.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: 7737512
• Report Number: 3005168196-2018-01492
• Device Sequence Number: 19494041
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 07/02/2018
• 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: 03/13/2026
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F82370
• 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: 07/02/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 24 YR
• Date Report Sent to FDA: 01/01/2005