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

Model Number	RBYLP0102
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the first returned ruby coil lp revealed offset coil winds along the length of its embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, while advancing the ruby coil lp through the returned non-penumbra microcatheter, resistance was encountered at the hub of the non-penumbra microcatheter and the ruby coil lp could not be advanced through the non-penumbra microcatheter.Evaluation of the second returned ruby coil lp revealed offset coil winds along the length of its embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation of the device revealed that the pet lock was separated on the proximal end of the pusher assembly, the pusher assembly was kinked and fractured, the pull wire was retracted from the ddt and the embolization coil was detached inside the introducer sheath.This damage was likely incidental to the complaint.Due to the returned damage, functional testing could not be performed.Evaluation of the third returned ruby coil lp revealed offset coil winds along the length of its embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, while advancing the ruby coil lp through the returned non-penumbra microcatheter, resistance was encountered at the hub of the non-penumbra microcatheter and the ruby coil lp could not be advanced through the non-penumbra microcatheter.Further evaluation of the device revealed pusher assembly kinks.This damage was likely incidental to the complaint.Evaluation of the returned non-penumbra microcatheter revealed that the ruby coil lp was unable to be advanced through the hub of the non-penumbra microcatheter.During functional testing, a demonstration ruby coil lp was attempted to advance through the non-penumbra microcatheter and resistance was encountered at the hub of the non-penumbra microcatheter and the ruby coil lp could not be advanced any further.The embolization coil of the demonstration ruby coil lp was found damaged after retracted from the microcatheter.Based on the functional testing result, the non-penumbra microcatheter likely contributed to the difficulty advancing the ruby coil lps during the procedure.Penumbra coils are visually 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 numbers: 3005168196-2020-02309, 3005168196-2020-02310.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps and non-penumbra microcatheter.During the procedure, the physician was unable to advance two ruby coil lps through the hub of the microcatheter.Therefore, both ruby coil lps were removed.Next, the physician placed a new ruby coil lp in the target vessel using the microcatheter; however, while attempting to advance another ruby coil lp, the same issued occurred.Therefore, it was removed.The procedure was completed using other 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: 11042136
• Report Number: 3005168196-2020-02308
• Device Sequence Number: 1307515
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/24/2020
• 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: 07/29/2025
• Device Model Number: RBYLP0102
• Device Catalogue Number: RBYLP0102
• Device Lot Number: F99206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Date Report Sent to FDA: 01/01/2005