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

Catalog Number RBY4C0860

Device Problems Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2018-00780, 3005168196-2018-00781, 3005168196-2018-00782, 3005168196-2018-00783.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached multiple ruby coils in the target vessel using the lantern.The physician then experienced resistance while advancing a ruby coil (f80435) through the middle of the lantern, and the ruby coil became stuck; therefore, the ruby coil was removed.While advancing another ruby coil (f73581) through the lantern, the physician experienced resistance again and the ruby coil pusher assembly broke; consequently, the ruby coil unintentionally detached and became stuck inside the lantern.Therefore, the physician removed the lantern from the patient with the detached ruby coil inside.Next, the physician placed a new lantern and attempted to advance another ruby coil (f79035); however, resistance was experienced again while advancing the ruby coil, and it became stuck inside the lantern; therefore, the ruby coil was removed.The physician then attempted to place another ruby coil (f77806); however, the ruby coil was retracted because it was too large for the target location.Later in the procedure, the physician attempted to use the same ruby coil again; however, resistance was experienced while this ruby coil was advancing through the middle of the lantern and it became stuck; therefore it was removed.It was reported that the pusher wire of this ruby coil became kinked while being packaged for return.The procedure was completed using additional coils and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pull wire was protruding distally from the ddt and sr wire was wrapped around the pusher assembly.The embolization coil had offset coil winds along its length concentrated on the proximal end.Conclusions: evaluation of the first ruby coil identified in the complaint revealed a device unable to advance out of its introducer sheath.The embolization coil had offset coil winds on its proximal end.Repeated manipulations of the embolization coil against resistance may result in some compression and offset winds on the coil.Further evaluation revealed the pull wire was protruding distally and the sr wire was wrapped around the ddt.If the embolization coil is forcefully advanced against resistance, the pull wire may protrude through the capture feature.The offset coil winds likely contributed to the resistance.While the coil winds may become compressed, the sr component length will not change and likely wrap around the ddt.Evaluation of the second ruby coil identified in the complaint revealed a detached coil within the first identified lantern.There were offset coil winds along the proximal length of the coil.If the coil is repeatedly advanced and retracted against resistance the embolization coil may be compressed and coil winds offset.These offset coil winds would likely contribute to any additional resistance experienced subsequently.This resistance would likely have contributed to the reported pusher assembly fracture, which would subsequently have allowed the pull wire to retract from the ddt detaching the coil.The subject pusher assembly was not returned and, therefore, the root cause of the unintentional detachment could not be determined.Evaluation of the first lantern identified in the complaint revealed a detached embolization coil within its lumen and some minor bends.The detached embolization coil is likely a result of the reported fractured pusher assembly.The minor proximal bends are likely a result of being in patient anatomy for an extended period of time and are incidental to the reported failure.During functional testing, a demonstration coil and one returned ruby coil were advanced through the device without issue.Evaluation of the third ruby coil identified in the complaint revealed a coil intact with the pusher assembly, offset coil winds, and a fractured sr wire.If the coil is repeatedly advanced and retracted against resistance the embolization coil may be compressed and coil winds offset.These offset coil winds likely contributed to additional resistance during the procedure.The distal tip of the coil was protruding from the sheath and the sr wire was fractured where the coil enters the sheath.If the coil were to become stuck on the tip of the introducer sheath while retracting, the sr wire will likely fracture at this location.Evaluation of the fourth ruby coil identified in the complaint revealed a kink on its proximal end.If the device is forcefully gripped the pusher assembly may kink.During functional testing, the coil was able to be advanced through both returned lanterns without issue.Resistance was experienced when removing the sheath over the proximal kink.The kink was inadvertently fractured by the penumbra investigator during functional testing.Evaluation of the second lantern revealed some clotted blood in the catheter lumen and minor bends.The clotted blood was flushed from the catheter.The minor bends were likely a result of being within anatomy for a period of time and were incidental to the reported failure.During functional testing, a demonstration and one returned ruby coil were advanced through the device without issue.Penumbra catheters and coils 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.

• 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: 7434753
• MDR Text Key: 105718478
• Report Number: 3005168196-2018-00779
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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
• Device Operator: Physician
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F80435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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: 61 YR
• Patient Weight: 39