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

Model Number	RBY4C1650-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 13.0 cm, 59.0 cm and 115.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds throughout its length.The introducer sheath was ovalized approximately 7.0 cm from its distal end.Conclusions: evaluation of the returned ruby coil revealed an ovalization on its introducer sheath.If the rotating hemostasis valve (rhv) is over rotated, damage such as this may occur.This damage likely contributed to the reported resistance experienced while advancing the ruby coil out of its introducer sheath.During functional testing, the ruby coil was able to advance through its introducer sheath with resistance due to the ovalization.A test mandrel was unable to advance through the ovalization on the introducer sheath.Further evaluation of the device revealed kinks on the pusher assembly and offset coil winds on the embolization coil.The offset coil winds on the embolization coil were likely a result of forceful advancement against resistance during the procedure.The kinks on the pusher assembly were 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.This report is associated with mfr report number:.3005168196-2020-01995.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils and a non-penumbra microcatheter.During the procedure, two ruby coils would not advance from the starting position of the introducer sheaths, and the physician experienced resistance.Therefore, the ruby coils were removed.The procedure was completed using new ruby coils.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: 10840743
• Report Number: 3005168196-2020-01994
• Device Sequence Number: 11644114
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 10/19/2020
• 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 Expiration Date: 01/18/2025
• Device Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F73898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• 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: 10/19/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005