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

Model Number	RBYLP0105
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-00962, 3005168196-2021-00964.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal (gi) bleed using ruby coil lps, a non-penumbra microcatheter, and a guidewire.During the procedure, a ruby coil lp would not advance past its initial position within its introducer sheath; therefore, it was removed.Subsequently, the same issue occurred with two other ruby coil lps; therefore, the ruby coil lps were also removed.The procedure was completed using additional ruby coil lps and the same microcatheter.There was no report of an adverse effect to the patient.It was reported that, upon further demonstration by the penumbra sales representative, one of the ruby coil lps advanced out of its introducer sheath.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp revealed offset coil winds on the embolization coil.This indicates that the device was likely able to advance from its initial position within its introducer sheath; therefore, the reported complaint could not be confirmed.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, the embolization coil may begin to take shape within the hub and resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the offset coil winds.Further evaluation revealed a pusher assembly kink, and the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage was likely incidental to the reported complaint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance; subsequently, additional resistance was experienced due to the offset coil winds, and the ruby coil lp was unable to be advanced out of the introducer sheath.Evaluation of the second returned ruby coil lp revealed offset coil winds on the embolization coil.This indicates that the device was likely able to advance from its initial position within its introducer sheath; therefore, the reported complaint could not be confirmed.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, the embolization coil may begin to take shape within the hub and resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the offset coil winds.Further evaluation revealed a pusher assembly kink, and the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage was likely incidental to the reported complaint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, and then through its introducer sheath without an issue.Resistance was experienced while attempting the ruby coil lp through a demonstration microcatheter due to the offset coil winds, and the ruby coil lp could not advance any further.Evaluation of the third returned ruby coil lp revealed 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 pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then resistance was experienced due to an unknown substance within the introducer sheath, and the ruby coil lp could not be advanced through the introducer sheath.The root cause of the unknown substance could not be determined.Further evaluation revealed a pusher assembly kink.This damage was 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 numbers: 3005168196-2021-00962; 3005168196-2021-00964.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11780498
• Report Number: 3005168196-2021-00963
• Device Sequence Number: 19744586
• Product Code: HCG
• UDI-Device Identifier: 00815948021730
• UDI-Public: 00815948021730
• 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): 04/08/2021
• 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: 07/26/2025
• Device Model Number: RBYLP0105
• Device Catalogue Number: RBYLP0105
• Device Lot Number: F99153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005