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

Model Number	RBYLP0310
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right lumbar artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician placed other lp coils in the target location using the microcatheter.While attempting to place a ruby coil lp in the target vessel, the hospital technologist was unable to advance the ruby coil lp past the friction lock.The ruby coil lp was flushed at the transition zone with saline and the coil was straightened out but, the ruby coil lp would not advance forward.Therefore, it was removed.The procedure was completed using other lp coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed pusher assembly kinks near the mid-joint.If the device is forcefully advanced against resistance, damage such as pusher assembly kinks may occur.Further evaluation revealed that the introducer sheath had kinks on its distal end.If the introducer sheath is forcefully mishandled during use, damage such as a kink may occur.This damage may have contributed to resistance during advancement.During functional testing, strong resistance was experienced while attempting to advance the ruby coil lp within its introducer sheath, and the coil could not be advanced at all.Further evaluation revealed additional pusher assembly kinks.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.H3 other text : placeholder.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11935714
• Report Number: 3005168196-2021-01248
• Device Sequence Number: 3363190
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 00815948021785
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/10/2021
• 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: 11/05/2025
• Device Model Number: RBYLP0310
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F101819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005