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

Model Number	RBYLP0860
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2020
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 renal artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while attempting to advance a ruby coil out of the microcatheter.Therefore, the ruby coil was removed.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-01526 1.Section e.Box 1.Initial reporter name and address please note that this complaint was submitted to the fda by the user facility with the following reference number: 0500690000-2020-8016 the following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or problem 2.Section e.Box 4.Initial reporter also sent report to fda 3.Section g.Box 3.Report source results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the smart coil was unable to be advanced from its returned position within the introducer sheath; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed properly.The smart coil was then advanced through its introducer sheath and a demonstration microcatheter without an issue.The introducer sheath was likely the reported microcatheter mentioned in 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left renal artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while attempting to advance a ruby coil out of the microcatheter hub.Therefore, the ruby coil was removed.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10556975
• Report Number: 3005168196-2020-01526
• Device Sequence Number: 2842854
• Product Code: HCG
• UDI-Device Identifier: 00815948021884
• UDI-Public: 00815948021884
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 08/28/2020
• 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: 03/05/2025
• Device Model Number: RBYLP0860
• Device Catalogue Number: RBYLP0860
• Device Lot Number: F96745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005