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

Catalog Number	RBY2C1035
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
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 numbers: 3005168196-2019-01363, 3005168196-2019-01365, 3005168196-2019-01366, 3005168196-2019-01367.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the celiac artery using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician placed a 115 cm lantern in the target vessel using a non-penumbra angiographic catheter and attempted to advance a ruby coil through the lantern; however, the physician was not satisfied with the coil position and decided to retract the ruby coil several times and repositioned the microcatheter.Consequently, the ruby coil became stuck inside of the microcatheter.Therefore, the lantern was removed containing the ruby coil.The physician then attempted to advance a 135 cm lantern through the angiographic catheter; however, it would only advance approximately 40 centimeters and would not advance any further.Therefore, the lantern was removed and one of the transition zones was found to be enlarged and elevated.Next, the physician placed a non-penumbra microcatheter in the target vessel and attempted to advance a new ruby coil; however, resistance was experienced and the ruby coil became stuck and would not advance past the distal tip of the microcatheter, therefore, the ruby coil was retracted.While retracting, the ruby coil broke within the microcatheter.Therefore, the physician successfully removed the ruby coil by pulling out the filament wire.The physician then experienced resistance while attempting to advance another ruby coil and the coil would not advance out of the microcatheter and, therefore, the ruby coil was retracted.While retracting, the ruby coil detached part way inside of the microcatheter.Therefore, the lantern was removed containing the ruby coil and the physician decided to end the procedure and, will continue the embolization procedure at a later date.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: 8787313
• Report Number: 3005168196-2019-01364
• Device Sequence Number: 16653701
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2019
• 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 Expiration Date: 08/15/2023
• Device Catalogue Number: RBY2C1035
• Device Lot Number: C07075
• 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: 06/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005