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	07/09/2021
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 number: 3005168196-2021-01676.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, a ruby coil lp advanced slightly in the introducer sheath but would then stop advancing.Subsequently, the ruby coil lp was removed.The physician attempted to advance a second ruby coil lp through the introducer sheath, and the same issue occurred.Therefore, the ruby coil lp was also removed.The procedure was completed using new ruby coil lps.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kink and fracture observed near the mid-joint.Further evaluation revealed additional pusher assembly bend and kinks, and the embolization coil was detached from the pusher assembly.The bends and kinks were likely incidental to the reported complaint.The detached embolization coil was likely a result of the pusher assembly fracture.Evaluation of the second returned ruby coil lp revealed that the device was returned without its introducer sheath; therefore, the reported inability to advance the coil within its introducer sheath could not be confirmed.Further evaluation revealed offset coil winds along the length of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.Based on the reported complaint, the root cause of resistance could not be determined.During functional testing.The ruby col lp was re-sheathed with a demonstration introducer sheath without an issue.Subsequently, while attempting to advance the ruby coil lp within the introducer sheath, resistance was experienced due to the offset coil winds, and the coil could not be advanced out of the introducer sheath.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: 1.3005168196-2021-01676.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12235920
• Report Number: 3005168196-2021-01675
• Device Sequence Number: 11665586
• Product Code: HCG
• UDI-Device Identifier: 00815948021730
• UDI-Public: 00815948021730
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 08/24/2021
• 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: 12/17/2024
• Device Model Number: RBYLP0105
• Device Catalogue Number: RBYLP0105
• Device Lot Number: F95061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005