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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 44.0 cm from the proximal end.The pusher assembly was fractured approximately 5.0, and 98.0 cm from the proximal end.The embolization coil was detached inside the introducer sheath.The introducer sheath also had coagulated blood inside.Conclusions: evaluation of the returned device revealed that the ruby coils pusher assembly was kinked and fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as a kinked pusher assembly may occur.If the ruby coil is removed from the patient after blood enters the introducer sheath and the ruby coil is not flushed prior to re-insertion into a microcatheter, dried blood inside the introducer sheath may contribute to resistance when advancing the ruby coil.If an already- kinked pusher assembly is further manipulated, it may result in a fractured pusher assembly.If the pusher assembly becomes fractured, it may allow the pull wire to withdraw from the distal detachment tip (ddt) and allow the embolization coil to detach.Since the embolization coil was returned inside the introducer sheath, the detachment of the embolization coil was likely incidental and occurred after successful withdrawal of the intact ruby coil from the lantern.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 treating an aneurysm and a dissection in the left common artery using ruby coils.During the procedure, the physician advanced a lantern delivery microcatheter (lantern) through a diagnostic catheter into the site of treatment and measured the aneurysm to be 11 centimeters.The physician then proceeded to advance a ruby coil through the lantern; however, while advancing the ruby coil and prior to detachment, the lantern kicked out the hypogastric artery with about 10 centimeters of the ruby coil advanced.Therefore, the physician removed the lantern in order to regain access to the target vessel.The ruby coil was re-sheathed; however, the technologist failed to flush it before resheathing it.After gaining access to the target vessel again, the physician attempted to advance the previous ruby coil through the same lantern; however, resistance was experienced and therefore, the ruby coil was removed.The procedure was completed using two new ruby coils and the same lantern with no issues.It should be noted that the physician did not use a rotating hemostasis valve(rhv) and the patient anatomy was described to be slightly tortuous.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: 6086039
• Report Number: 3005168196-2016-01570
• Device Sequence Number: 757454
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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: Physician
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F64765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR