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

Catalog Number	RBY2C0530
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the varicelle artery using a ruby coil.During the procedure, the physician placed a ruby coil through the lantern delivery microcatheter (lantern) and resistance was encountered.While extracting, a "pop" was felt and it was observed that the ruby coil had unraveled.Therefore, the ruby coil was removed.The procedure was successfully completed by using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 5.0, 14.0, and 124.0 cm from the proximal end.The pusher assembly was fractured at approximately 69.0 cm from the proximal end.The stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was present inside the distal detachment tip (ddt).The embolization coil was detached from its pusher assembly and unraveled.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured.If the device is forcefully retracted against resistance, damage such as a sr wire fracture may occur.The sr wire fracture was likely the pop that was observed during retraction of the ruby coil.The lantern identified in the complaint was not returned for evaluation and, therefore, the root cause of resistance could not be determined.Further evaluation of the returned ruby coil revealed kinks and a fracture in the pusher assembly.These damages were likely incidental to the reported complaint.Penumbra coils are visually 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.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the resistance.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8808723
• Report Number: 3005168196-2019-01409
• Device Sequence Number: 10876948
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019
• 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: 08/22/2024
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F71288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005