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

Model Number	RBYLP0105
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp pusher assembly revealed that the introducer sheath was fractured at its proximal end and the fractured proximal segment was not returned for evaluation.Based on the reported complaint, this damage was likely a result of the introducer sheath being cut during the procedure.Further evaluation of the device revealed that the pet lock was separated on the proximal end of the pusher assembly.If this occurs, the pull wire will retract from the pusher assembly distal detachment tip and the embolization coil will detach from the pusher assembly.The root cause of the separated pet lock could not be determined.The detached embolization coil was not returned for evaluation.Due to the returned condition, the root cause of the reported complaint could not be determined.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.Conclusions code 1: (b)(4) - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report numbers: 3005168196-2021-01490, 3005168196-2021-01491.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pseudoaneurysm using ruby coil lps and a microcatheter.During the procedure, three ruby coil lps would not advance at all past their initial positions within their introducer sheaths.Subsequently, the scrub technologist removed the ruby coil lps from the backside of the introducer sheaths, cut the friction locks, and backloaded the introducer sheaths.It was reported that, while attempting to remove one of the ruby coil lps from the backside of its introducer sheath, resistance was encountered, and the ruby coil lp detached from its pusher assembly on the back table.The physician then successfully placed the remaining two ruby coil lps in the target vessel.The procedure was completed using additional lp coils.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: 12133208
• Report Number: 3005168196-2021-01489
• Device Sequence Number: 11916064
• 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
• Report Date (Section B): 07/07/2021
• 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: 01/11/2026
• Device Model Number: RBYLP0105
• Device Catalogue Number: RBYLP0105
• Device Lot Number: F103228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• 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: 06/08/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005