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

Model Number	RBY4C1650-A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
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 hepatic arteriovenous malformation (avm) using ruby coils and non-penumbra catheter.During the procedure, the physician placed multiple coils in the venous sack of the avm using the catheter.Subsequently, the physician experienced resistance after advancing another ruby coil approximately four centimeters within the introducer sheath and the ruby coil would not advance.Therefore, it was removed.The procedure was completed using additional ruby coils and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed offset coil winds along the length of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, the ruby coil was unable to be advanced through its introducer sheath due to the offset coil winds and functional testing could not be continued.The root cause of the reported resistance during the procedure could not be determined.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: 11179933
• Report Number: 3005168196-2021-00101
• Device Sequence Number: 2270675
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 12/23/2020
• 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: 01/31/2022
• Device Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F40982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Date Report Sent to FDA: 01/01/2005