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

Model Number	RBY4C0204-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed offset coil winds.If the device is advanced against resistance, damage such as this may occur.During functional testing, the ruby coil was re-sheathed using a demonstration introducer sheath without an issue.The ruby coil was then advanced out of the introducer sheath and a demonstration microcatheter without an issue.The root cause of resistance during the procedure could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.(b)(4).The investigation findings do not lead to a clear conclusion about the root cause of the resistance during the procedure.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a left epigastric bleed using ruby coils and a non-penumbra microcatheter.During the procedure, the physician successfully placed a ruby coil into the target location using the microcatheter.Next, the physician experienced resistance while delivering the next ruby coil.Therefore, the ruby coil was removed.The procedure was completed using two new ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11972572
• Report Number: 3005168196-2021-01295
• Device Sequence Number: 4229425
• Product Code: HCG
• UDI-Device Identifier: 00814548018270
• UDI-Public: 00814548018270
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 05/11/2021
• 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: RBY4C0204-B
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F104738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005