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

Model Number	RBY2C1660-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01290.3005168196-2020-01291.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pelvic pain disease in the ovarian varicose vein using a px slim delivery microcatheter (px slim) and ruby coils.During the procedure, the physician advanced a ruby coil approximately four to five centimeters and the physician was not satisfied; therefore, the ruby coil was retracted back into the px slim.While re-advancing the ruby coil through the px slim, the ruby coil became stuck within the px slim.Therefore, the ruby coil was removed.The physician advanced another ruby coil a few centimeters and was unsatisfied with the ruby coil deployment and retracted the ruby coil back within the px slim.While re-advancing the ruby coil through the px slim, the ruby coil became stuck within the px slim.Therefore, the ruby coil and px slim were removed.The procedure was completed using non-penumbra coils and a microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.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 numbers: 1.3005168196-2020-01290, 2.3005168196-2020-01291 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10457264
• Report Number: 3005168196-2020-01292
• Device Sequence Number: 14333697
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter Country: VM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020
• 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: RBY2C1660-A
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F90598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Date Report Sent to FDA: 01/01/2005