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

Catalog Number	RBY2C0415
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Please note that it is unknown which ruby coil lot # belongs to which reported issue.Therefore, the same evaluation codes will be provided on this initial mfr report and its associated mfr report.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: 3005168196-2017-00020.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician deployed an initial ruby coil into the target vessel using another manufacturer's microcatheter without resistance and then attempted to detach the coil using a ruby coil detachment handle (handle).However, the ruby coil did not release from its pusher assembly and was retracted back out through the microcatheter.The physician did not believe that there was an issue with the handle and opened a second ruby coil.While attempting to advance the coil through the microcatheter, the physician met resistance and the coil became stuck inside the microcatheter.Therefore, the microcatheter containing the second ruby coil was removed and the procedure was completed using non-penumbra coils and a new non-penumbra microcatheter.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush.However, the microcatheter was flushed in between each coil used during the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and the pull wire was retracted on the proximal end of the first ruby coil evaluated.The embolization coil was intact with its pusher assembly due to coagulated blood.The coagulated blood was flushed off by the penumbra investigator for further evaluation.The inner diameter (id) of the distal detachment tip (ddt) was measured and found to be within specification.The outer diameter (od) of the proximal constraint sphere was measured and found to be within specification.The pet lock was intact on the proximal end of the pusher assembly of the second ruby coil evaluated.The pusher assembly was kinked approximately 32.0, 74.5, and 88.0 cm from the proximal end.The embolization coil was stuck inside the non-penumbra microcatheter intact with its pusher assembly.Conclusions: evaluation of the first returned ruby coil revealed that the embolization coil was attached to the pusher assembly by coagulated blood.During decontamination of the ruby coil, the disinfectant solution softened the coagulated blood and the embolization coil detached from its pusher assembly without using force.Further evaluation determined that the ddt id and the proximal constraint sphere od were within specification.The root cause of the inability of the coil to detach could not be determined.Evaluation of the second ruby coil revealed that the embolization coil was stuck inside an ovalized non-penumbra microcatheter.If the ruby coil is used with a damaged microcatheter, it is likely that resistance may occur.Further evaluation of the returned device revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6231113
• Report Number: 3005168196-2017-00021
• Device Sequence Number: 673883
• Product Code: HCG
• UDI-Device Identifier: 00814548012858
• UDI-Public: 00814548012858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/09/2016

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: 06/27/2024
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F70362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1