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

Model Number	RBY4C0835-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
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.This report is associated with mfr report number: 3005168196-2020-00965.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lienal artery using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician placed four penumbra coils in the target vessel using the handle.While attempting to detach the last ruby coil, the handle failed to detach the ruby coil.Therefore, the ruby coil was removed.The procedure ended after the coil was removed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends and kinks were present throughout the length of the pusher assembly.The introducer sheath was loaded backwards onto the ruby coil.The embolization coil was intact with the pusher assembly.The introducer sheath was ovalized approximately 20.0 cm from the proximal end and offset coil winds were present at the ovalization.Conclusions: evaluation of the returned ruby coil could not confirm the reported complaint.During functional testing, a demonstration handle was used to detach the ruby coil embolization coil without an issue.Further evaluation revealed pusher assembly kinks, offset coil winds, an ovalization in the introducer sheath and the introducer sheath was loaded backwards onto the ruby coil.These damages 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: 1.3005168196-2020-00965.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10289641
• Report Number: 3005168196-2020-00964
• Device Sequence Number: 812429
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• 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): 06/23/2020
• 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 Model Number: RBY4C0835-A
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F94957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005