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

Catalog Number	RBY2C1660
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly and stuck inside the returned lantern.The proximal constraint sphere was not present inside the distal detachment tip (ddt) and the ddt was damaged.Conclusions: 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; 3005168196-2018-01758; 3005168196-2018-01760.
Event or Problem 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7857465
• Report Number: 3005168196-2018-01759
• Device Sequence Number: 16552401
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 08/10/2018
• 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: 05/24/2025
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F77348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• 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: 08/10/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005