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

Catalog Number	RBY2C2457
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization in the splenic artery procedure using ruby coils.During the procedure, the physician successfully placed four ruby coils using a lantern delivery microcatheter (lantern).The physician then felt resistance while advancing another ruby coil into the lantern and, therefore, the ruby coil was removed and re-sheathed.It was reported that the pusher assembly of the ruby coil was slightly kinked.The physician then flushed the lantern and was able to successfully advance a guidewire through the lantern.Therefore, the physician attempted to re-advance the same ruby coil, however, the coil was unable to advance and the ruby coil became stuck between a neuron 6f 070 delivery catheter (neuron 070) and neuron select catheter 5f (5f select).Therefore, the lantern, 5f select, and neuron 070 were removed with the ruby coil inside.The pusher assembly of the ruby coil then became kinked in several more locations.The physician then reinserted the same neuron 070, 5f select, and lantern, and then successfully placed additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly was fractured approximately 82.5 cm from the proximal end and the pull wire was retracted out of the distal fractured segment.The pusher assembly had bends and kinks approximately 10.0 cm, 23.0 cm, 28.0 cm, 48.0 cm, 67.5 cm, 68.5 cm, 77.0 cm, 86.0 cm and 101.0 cm from the proximal end.The introducer sheath was on the distal fractured segment of the pusher assembly.The embolization coil was detached from the distal detachment tip (ddt) and had offset coil winds along the length of the coil.The ddt was damaged.Conclusions: evaluation of the returned ruby coil revealed a damaged pusher assembly and an embolization coil with offset coil winds.The complaint reported that the ruby coil was stuck between the 5f select and the neuron 070 and an rhv was not used.If an rhv is not used during the procedure, the 5f select may shift inside the neuron 070 and the ruby may become stuck between the two devices.This may have contributed to the experienced resistance.If the device is advanced against resistance, damage such as offset coils winds, damaged distal detachment tip (ddt), and a kinked pusher assembly may occur.These damages are likely due to advancing the device against resistance.Further evaluation revealed a fracture and additional kinks on the pusher assembly.Based on the return condition and the reported complaint, this damage is likely incidental to the complaint and may have occurred during packaging for return to penumbra.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: 8137658
• Report Number: 3005168196-2018-02370
• Device Sequence Number: 262713
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 11/06/2018
• 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: 02/20/2026
• Device Catalogue Number: RBY2C2457
• Device Lot Number: C09220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005