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

Catalog Number RBY2C0840

Device Problems Detachment Of Device Component (1104); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-01132, 3005168196-2018-01133, 3005168196-2018-01134, 3005168196-2018-01135, 3005168196-2018-01136.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a renal aneurysm using ruby coils and a ruby coil detachment handle (handle).During the procedure, while attempting to advance a ruby coil into a non-penumbra microcatheter, the physician noticed that the ruby coil was not advancing into the microcatheter; therefore, it was removed.It was reported that same issue occurred with four other ruby coils.Upon turning on the lights in the operating room, it was noticed that the embolization coils were on the ground.It was concluded that the five ruby coils, unknowingly at the time, had detached upon removal from the packaging hoops prior to the attempts made to advance them into the microcatheter.Next, the physician advanced a new ruby coil in the target vessel and used a handle to successfully detach it; however, it was reported that the ruby coil pusher assembly became stuck in the handle.The procedure was completed using a new handle, additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was wrinkled on the proximal end of the pusher assembly.The ruby coil pusher assembly was fractured approximately 5 cm from the proximal end and the pull wire was retracted from the ddt.The pusher assembly was kinked approximately 38.0, 63.0, and 91.0 cm from the proximal end.The embolization coil was detached and had offset coil winds.Conclusions: the first ruby coil evaluated revealed a damaged pet lock and detached embolization coil.The pet lock had become loose on the pusher hypotube and was retracted such that the pull wire was retracted from the ddt.If the pull wire is retracted it will result in the detachment of the embolization coil.If the ruby coil is mishandled during removal from the packaging or during preparation it may contribute to the pet lock becoming detached.Evaluation of the second, third, and fourth returned ruby coils revealed similar damage.The returned ruby coil pusher were all broken on their proximal end and had detached embolization coils.If the pusher assembly becomes fractured, it will likely contribute to pull wire becoming retracted from the ddt and detach the embolization coil.Further evaluation revealed the pet locks were all damaged similar to the first returned ruby coil.This further supports these devices were likely mishandled in a similar way during removal from the packaging and preparation that may have contributed to the reported complaint.A detached embolization coil was received with the fourth returned ruby coil.The coil was detached and has offset coil winds on it.The report states these coils were discovered on the floor of the operating room.Therefore, these damages were likely incurred after becoming detached as a result of fracturing the pusher assembly.Further evaluation also revealed kinked in different locations on the returned ruby coil pusher assemblies.These kinks were likely incidental to the reported failure.Evaluation of the returned handle revealed that a fracture pusher assembly was stuck inside the handle.If the handle is forcefully advanced through the handle nose cone or repeatedly actuated in attempt to detach the coil it may become lodged within the handle mechanism.After removal of the pusher assembly, the handle performed within specification.No other devices associated with the complaint were returned for evaluation.Penumbra handles are visually inspected and functionally tested during incoming quality inspection.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report numbers: 3005168196-2018-01132, 3005168196-2018-01133, 3005168196-2018-01134, 3005168196-2018-01135, and 3005168196-2018-01136.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7580723
• MDR Text Key: 110466346
• Report Number: 3005168196-2018-01137
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012988
• UDI-Public: 00814548012988
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0840
• Device Lot Number: F77219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1