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

Model Number	RBY4C0315-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery using ruby coils, a lantern delivery microcatheter (lantern), and an angiographic catheter.It was noted that the patient anatomy was mildly tortuous and calcified.During the procedure, while advancing the first ruby coil approximately five centimeters into the lantern, the physician experienced resistance and decided to remove the ruby coil.Upon removal, the ruby coil unintentionally detached at the hub of the lantern.Therefore, the lantern and detached ruby coil were removed together.The procedure was completed using a new ruby coil, a pod coil, a pod packing coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Further evaluation of the device revealed that the pull wire was retracted from its alignment feature and advanced distal to the ddt.If the device was forcefully retracted against resistance, the pusher assembly may become elongated and the pull wire may retract from its alignment feature to allow the embolization coil to detach from its pusher assembly.Further investigation also revealed that the pet lock was broken, and the embolization coil had offset coil winds.This damage was likely incidental to the 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: 11183249
• Report Number: 3005168196-2021-00109
• Device Sequence Number: 4017759
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020
• 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: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F89669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005