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

Catalog Number	RBY4C0406
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	03/15/2019
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: 3005168196-2019-00693; 3005168196-2019-00694.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric artery using pod packing coils (pod pcs) and ruby coils.During the procedure, the physician successfully placed a pod14 coil in the target location using a non-penumbra microcatheter.The physician then experienced resistance while attempting to advance a pod pc from its initial position within its introducer sheath.The physician therefore removed the pod pc and was able to successfully place a new pod pc in the target vessel.While attempting to advance a ruby coil, the physician experienced resistance at the hub of the microcatheter and reported that it would not advance any further.The ruby coil was then removed and was not used in the procedure.It was also reported that the physician felt resistance while attempting to advance another ruby coil from its initial position within its introducer sheath.This ruby coil was also removed and was no longer used in the procedure.It was noted that the physician flushed the non-penumbra microcatheter after implanting each coil into the target vessel.The procedure was completed using additional pod pcs.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: 8508988
• Report Number: 3005168196-2019-00696
• Device Sequence Number: 16501979
• Product Code: HCG
• UDI-Device Identifier: 00814548018331
• UDI-Public: 00814548018331
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 03/15/2019
• 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 Catalogue Number: RBY4C0406
• Device Lot Number: F87337
• 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: 03/15/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005