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

Model Number	RBY4C0835-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
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: 3005168196-2020-00954.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortic valve using ruby coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter.During the procedure, the physician was unable to visualize the distal end of the lantern after advancing it through the catheter and into the nidus of the arteriovenous malformation (avm).After an unsuccessful attempt to inject contrast through the lantern, the physician attempted to deliver a ruby coil through the lantern; however, the coil became stuck.The physician then determined that the lantern had curled up several times over in the nidus and had become kinked, preventing the ruby coil from advancing further through the lantern.Therefore, the lantern and ruby coil were removed together from the patient.The procedure was completed using a new lantern and additional 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
• MDR Report Key: 10287550
• Report Number: 3005168196-2020-00955
• Device Sequence Number: 16346819
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 00814548018386
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 06/24/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY4C0835-B
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F95810
• 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: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 88
• Date Report Sent to FDA: 01/01/2005