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

Catalog Number	RBY4C0630
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-01728.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to advance two ruby coils within a non-penumbra microcatheter and, therefore, the ruby coils were removed.The procedure was completed using new coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal pet lock was intact.The pusher assembly was kinked approximately 118.0 cm and 120.0 cm from the proximal end.The embolization coil was damaged, the sr wire was fractured on its distal end and the sphere was intact with the pusher assembly.Conclusions: evaluation of the returned ruby coils revealed offset coil winds, kinks on the pusher assembly and fractured sr wires.If the ruby coil is advanced against resistance, damage such as offset coil winds and kinks may occur.The stretch resistant wire fractures typically occur as a result of forcefully retracting the embolization coils against resistance.Based on the reported complaint, several kinks and embolization coil damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.The non-penumbra microcatheter was not returned to penumbra for evaluation; therefore, the root cause of the resistance was unable to be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7846829
• Report Number: 3005168196-2018-01727
• Device Sequence Number: 11051729
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 08/06/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2026
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F81421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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