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

Catalog Number	RBY2C3260
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the third ruby coil pusher assembly evaluated.The pusher assembly was kinked approximately 5.0 and 12.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the distal detachment tip (ddt) was fractured off the distal tip of the pusher.Conclusions: evaluation of the first returned ruby coil revealed that the sr wire was fractured.This type of damage typically occurs due to forceful retraction against resistance.Based on the return condition of the ruby coil, the root cause of resistance during advancement could not be determined.The sr wire fracture likely cause the coil to detach within the lantern.Evaluation of the second returned ruby coil revealed that the embolization coil was detached from its pusher assembly.If the device is forcefully retracted against resistance, the polymer section of the pusher assembly may elongate beyond the reach of the pull wire inside the ddt, and likely result in the embolization coil detaching from its pusher assembly.Further evaluation of the returned ruby coil revealed that the introducer sheath was ovalized.If the rotating hemostasis valve (rhv) is overtightened on the introducer sheath, damage such as this may occur.The ovalization in the introducer sheath likely contributed to resistance and the coil becoming stuck.Evaluation of the third returned ruby coil revealed that the ddt was fractured off the distal tip of the pusher assembly.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of this resistance could not be determined as the subject lantern was not returned for evaluation.The ddt fracturing off the distal tip of the pusher assembly contributed to the embolization coil detaching within the lantern.In addition, the ddt is what keeps the embolization coil intact with its pusher assembly.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported issue and may have occurred due to packaging of the device for return to penumbra.The two lantern identified in the complaint and 1 of 3 pusher assemblies were not returned for evaluation.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 3005168196-2018-01556, 3005168196-2018-01557, 3005168196-2018-01558, 3005168196-2018-01559.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the peroneal artery using ruby coils and lantern delivery microcatheters (lantern).During the procedure, while advancing a ruby coil through the lantern, the ruby coil unintentionally detached and became stuck within the lantern.Therefore, the physician removed the lantern containing the detached coil.The physician successfully deployed and detached two ruby coil using a second lantern.The physician then attempted to advance another ruby coil through the lantern; however, the coil became stuck in the microcatheter and was removed.The physician attempted to place a new ruby coil, however again the coil unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil.The procedure was completed using other coils and other catheter.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: 7773074
• Report Number: 3005168196-2018-01560
• Device Sequence Number: 13706010
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/12/2018
• 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: 03/14/2025
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F75020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• 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: 07/12/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005