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

Model Number	RBY4C0860-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 left internal iliac artery (iia) using a ruby coil.During the procedure, the physician experienced resistance while advancing a ruby coil within its introducer sheath.Subsequently, the ruby coil would not advance at all from its initial position within its introducer sheath.Therefore, the ruby coil was removed.The procedure was completed using another ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ruby coil revealed that the proximal end of the introducer sheath was stretched.If the ruby coil is forcefully advanced against resistance while gripping the introducer sheath, damage such as stretching may occur.During the functional test, resistance was encountered while attempting to advance the embolization coil due to the stretched introducer sheath, and the device could not be advanced at all.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during advancement against resistance or packaging for return.Penumbra coils are visually 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using a ruby coil.During the procedure, the physician experienced resistance while advancing a ruby coil within its introducer sheath.Therefore, the ruby coil was removed.The procedure was completed using another ruby coil.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: 12018989
• Report Number: 3005168196-2021-01359
• Device Sequence Number: 3673799
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• 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): 08/26/2021
• 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: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F102613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005