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

Catalog Number RBY2C1857

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Results: he pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 29.0, 44.0 and 85.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the introducer sheath had coagulated blood inside.Conclusions: evaluation of the lantern revealed an ovalization on its distal shaft.If the lantern is mishandled during preparation or forcefully manipulated within patient anatomy an ovalization may occur.One of the returned ruby coils was detached and stuck within the lantern ovalization; therefore, the device was unable to be functionally tested.Evaluation of the returned ruby coils revealed kinked pusher assemblies.If the ruby coils are forcefully advanced against resistance the pusher assembly may become kinked.The ovalization in the returned lantern likely contributed to the resistance experienced during the procedure.Further evaluation revealed the second ruby coil evaluated was detached.If the ruby coil is forcefully advanced into the lantern ovalization, additional resistance may be experienced upon attempts to retract the device.If the ruby coil is forcefully retracted against resistance the embolization coil may become detached.Further evaluation also revealed the ddt was damaged.The root cause of the damaged ddt could not be determined.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: 3005168196-2018-01757, 3005168196-2018-01759, 3005168196-2018-01760.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached a ruby coil in the target vessel using a lantern.While attempting to advance a new ruby coil through the lantern, the ruby coil became stuck; therefore, it was removed.It was reported that the same issue occurred with two other ruby coils; therefore, the lantern and ruby coils were removed.The procedure was completed using a new lantern and other coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7857466
• MDR Text Key: 119647277
• Report Number: 3005168196-2018-01758
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F75012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• 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: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR