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

Model Number RBY4C0860-B

Device Problems Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00557.

Event Description

The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed five coils in the target vessel using the lantern.While advancing the next coil, a ruby coil, through the lantern and into the vessel, the physician experienced mild resistance, and the ruby coil unintentionally detached.The physician then pushed the ruby coil further and successfully placed it in the target vessel. while removing the pusher assembly from the lantern, the pusher assembly broke and part of it came out of the lantern.Once lantern was removed, it was noticed that the other part of the pusher assembly was left behind in the vessel; therefore, a snare device was used to successfully remove that part. the procedure was completed using another ruby coil and another lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was bunched and retracted from the pusher assembly.The pull tube and the pull wire were retracted from the pusher assembly.The pusher assembly was fractured, and the returned distal portion of the fractured pusher assembly had approximately 85.0 cm in length.The proximal potion of the fractured pusher assembly was not returned.The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned ruby coil pusher assembly confirmed that the pusher assembly was fractured.The flattening at the location of fracture suggest this was due to the pusher assembly becoming kinked prior to fracture.If the pusher assembly is manipulated at extreme angles or against resistance it may become kinked.If a kinked pusher assembly is manipulated, it may eventually fracture.The implanted embolization coil, the proximal portion of the fractured pusher assembly and the lantern used in the complaint were not returned for evaluation.Penumbra coils are 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 number: 1.3005168196-2020-00557.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9965177
• MDR Text Key: 187863001
• Report Number: 3005168196-2020-00556
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• 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: 01/01/2005,03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBY4C0860-B
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F92788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR