MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL

Catalog Number	RBY2C0435
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The device pusher assembly had ovalization approximation 1.0 cm from the distal detachment tip.The embolization coil was intact with the distal detachment tip.The embolization coil had offset coil winds.Pusher assembly had bends approximately 86.0 cm and 100.0 cm.Conclusions: evaluation of the returned device revealed damage along the length of the embolization coil and on the distal end of the pusher assembly.This damage can typically occur when manipulating the embolization coil against resistance.The px slim identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance could not 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a vertebral artery using ruby coils.During the procedure, the physician successfully placed six pod coils using a px slim delivery microcatheter (px slim).It was reported that the physician then felt resistance while advancing a ruby coil within the px slim and that the ruby coil became stretched.Therefore the ruby coil was removed.The procedure was then completed using a new ruby coil and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8035731
• Report Number: 3005168196-2018-02158
• Device Sequence Number: 1498592
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2018
• 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: 11/08/2024
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F72750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• 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: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• 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