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

Catalog Number	RBY2C0420
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2017-01042, 3005168196-2017-01043, 3005168196-2017-01045.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using neuron 6f 070 delivery catheters (neuron 070¿s) and ruby coils.It was noted that the patient had a very tortuous anatomy.During the procedure, the physician tried to gain access using a non-penumbra 6f sheath and a neuron 070, with a non-penumbra select catheter loaded in the neuron 070.While attempting to advance the neuron 070 through the sheath, the physician inadvertently kinked the neuron 070.Therefore, the neuron 070 was removed and a new neuron 070 was opened; however, the physician was unable to access the celiac trunk with this system because of the tortuosity of the patient.The neuron 070 system was removed and a non-penumbra select catheter was used to select the celiac and access the distal part of the vessel with a lantern delivery microcatheter (lantern).After that, the physician successfully deployed and detached a ruby coil into the target vessel.While the physician was attempting to advance two new ruby coils out of the lantern and into the target vessel, both coils were very stiff to advance and resistance was met.Therefore, the physician successfully removed both coils and placed several new ruby coils in the outflow and into the aneurysm using the same lantern.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and subsequently, the ruby coil unintentionally detached partially inside the lantern and some of the coil outside of the lantern.Therefore, the physician removed the lantern containing the detached coil as it was unraveling inside the lantern.The procedure was then successfully completed using a new lantern and two additional ruby coils.There was no alleged deficiency against the first lantern.The physician just wanted to switch to a new lantern since he had been using the first lantern for three hours.It was also noted that there was no alleged deficiency against the second neuron 070.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil.The pusher assembly was kinked in multiple locations throughout its length.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the neuron 070 revealed that it was ovalized on the distal tip.This damage may have occurred due to forceful manipulation of the neuron 070 during navigation of tortuous patient anatomy.The kinks in the neuron 070 were likely incidental and may have occurred during packaging for return.Evaluation of ruby coil with lot # f44454 revealed that the embolization coil was detached within the introducer sheath and dried blood was inside the introducer sheath.Since this ruby coil was reported as successfully removed from the procedure with no mention of unintentional detachment, this detachment was likely incidental and likely occurred after removal from the procedure.Evaluation of ruby coil with lot # f72748 revealed that the embolization coil was detached and the stretch resistant (sr) wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach from the pusher assembly.Since this ruby coil was reported as successfully removed from the procedure with no mention of unintentional detachment, this detachment was likely incidental and likely occurred after removal from the procedure.Evaluation of ruby coil with lot # f65716 revealed that the embolization coil was detached and the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach from the pusher assembly.The kinks observed on the pusher assemblies were likely incidental and may have occurred during packaging for return to penumbra.The lantern delivery microcatheter (lantern) was not returned for evaluation.Penumbra coils and catheters 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6675726
• Report Number: 3005168196-2017-01044
• Device Sequence Number: 81556
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 05/31/2017

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: Physician
• Device Expiration Date: 11/08/2024
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F72748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR