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

Model Number	RBY2C1240-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pancreaticoduodenal artery aneurysm (pda) using ruby coils, a ruby coil detachment handle (handle) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the ruby coil in the target vessel using the lantern and attempted to detach it using the handle; however, the ruby coil failed to detach after multiple attempts.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil, the same handle and lantern.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 pusher assembly.The ruby coil was advanced through its introducer sheath.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Coagulated blood was within the ddt.The embolization coil was knotted and had offset coil winds throughout its length.Conclusions: evaluation of the returned ruby coil revealed that the pet lock on the proximal end of the pusher assembly was intact.If the proximal end of the pusher assembly is not properly inserted into a handle, the pull tube may not retract when the handle is actuated, and the pet lock will not separate and the embolization coil remain intact with the pusher assembly.During functional testing, the ruby coil was attempted to be detached using a demonstration handle.The handle was actuated, and the pet lock separated and pull wire retracted, but the embolization coil remained intact with the pusher assembly ddt due to coagulated blood.The coagulated blood was likely incidental to the reported complaint.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: 10587292
• Report Number: 3005168196-2020-01574
• Device Sequence Number: 16455254
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020
• 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 Model Number: RBY2C1240-A
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F89118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005