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

Model Number	RBYPCLP10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 lumbar artery using ruby coil lps, packing coil lps, lp system detachment handle (handle), and non-penumbra microcatheter.During the procedure, the physician placed multiple ruby coil lps in the target vessel using the microcatheter.Subsequently, two ruby coil lps and a packing coil lp would not advance past the friction lock within its introducer sheath on the back table.Therefore, both ruby coil lps and the packing coil lp were not used in the procedure.The physician then advanced a new packing coil lp into the vessel and used the handle to detach it; however, the packing coil lp failed to detach.Therefore, it was removed.The procedure was completed using a new ruby coil lp with the same handle and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the second returned packing coil lp confirmed that the embolization coil was intact with the pusher assembly.Further evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pusher assembly had a severe kink on the mid-shaft.The root cause of the kink could not be determined; however, if the pusher assembly is severely kinked, the pull wire may become pinned within the pusher assembly hypotube.This may cause resistance during attempts to detach the coil using a handle, and the pull wire may not retract.During functional testing, the packing coil lp was attempted to be detached using a demonstration handle but was unsuccessful as the pull wire did not retract from its returned position.Further evaluation revealed additional pusher assembly kinks and offset coil winds on the embolization coil.This damage may be 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: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11356623
• Report Number: 3005168196-2021-00318
• Device Sequence Number: 3711690
• Product Code: HCG
• UDI-Device Identifier: 00815948021914
• UDI-Public: 00815948021914
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022
• 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: 11/18/2025
• Device Model Number: RBYPCLP10
• Device Catalogue Number: RBYPCLP10
• Device Lot Number: F102152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Is the Reporter a Health Professional?: Yes
• 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: 01/25/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 02/21/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005