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

Catalog Number RBY4C0415

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the reported issue cannot be confirmed and 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.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a pseudoaneurysm using ruby coils.During the procedure, the ruby coil unintentionally detached as it was being retracted into the lantern delivery microcatheter (lantern).Although there was no report of an adverse effect on the patient, multiple attempts have been made to gather additional information.As of 14-september-2017, no additional information is available.

Event Description

The patient was undergoing a coil embolization procedure in the inferior pancreaticoduodenal artery (ipda) using ruby coils.During the procedure, the physician attempted to retract a ruby coil back into a lantern delivery microcatheter (lantern) to reposition it.However, the physician felt resistance retracting and the ruby coil unintentionally detached near the hub of the lantern.The physician removed the pusher wire and injected contrast into the lantern, thinking that the coil implant had been removed with the pusher wire.Consequently, the ruby coil was flushed into the patient, and the physician therefore made a second puncture below the sheath and used a snare device to retrieve the ruby coil.The procedure was completed using additional coils and a new microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 09/26/2017: patient identifier, age at time of event and age unit, sex, adverse event and/or product problem, outcomes attributed to adverse event (select all that apply), describe event or problem, phone, date received by manufacturer (mm/dd/yyyy), type of reportable event, if follow-up, what type?.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6865705
• MDR Text Key: 86160519
• Report Number: 3005168196-2017-01549
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F74577
• Was Device Available for Evaluation?: No
• 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: 09/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR