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

Model Number	RBY2C1660-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 splenic artery using ruby coils and a non-penumbra microcatheter.During the procedure, the physician successfully placed the first ruby coil in the target vessel using the microcatheter.However, the next ruby coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using two ruby coils and the same microcatheter.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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was retracted from the proximal end of the introducer sheath.The embolization coil was intact with the pusher assembly and had offset coil winds.The embolization coil was compressed and stuck within the introducer sheath friction lock.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil was unable to be advanced out of the introducer sheath.This was due to the pusher assembly being retracted out of the proximal end of its introducer sheath and the embolization coil was stuck within the introducer sheath friction lock.The embolization coil outer diameter is slightly larger than the introducer sheath friction lock inner diameter.If the pusher assembly is retracted beyond the introducer sheath friction lock, the embolization coil will get stuck within the friction lock due to the larger outer diameter of the embolization coil.If the pusher assembly is retracted further while the embolization coil is stuck within the friction lock, the embolization coil may become compressed and result in offset coil winds.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: 9660821
• Report Number: 3005168196-2020-00121
• Device Sequence Number: 16992395
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 01/09/2020
• 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: F91991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005