MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Model Number	4002C2060-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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-.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left and right pelvic veins using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim), a non-penumbra diagnostic catheter and non-penumbra coils.During the procedure, the physician successfully placed a px slim in the left pelvic vein.Then, while advancing approximately ten centimeters of a pc400 through the px slim, the pc400 became stuck.It was reported that multiple attempts were made to advance the pc400; however, resistance was noted and consequently, the pc400 remained stuck within the px slim.Therefore, the pc400 was removed.Next, the physician placed non-penumbra coils in the target location using the px slim.Afterwards, the physician successfully placed the px slim in the right pelvic vein.Then while the physician advanced approximately ten centimeters of another pc400 through the px slim, the same issue occurred.The pc400 became stuck within the px slim.Therefore, the pc400 was removed.The procedure was completed using other coils and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 revealed that the pet lock was slipped off from its initial position but still intact on the proximal end of the pusher assembly.If the proximal end of the pusher assembly is forcefully gripped and maneuvered at extreme angles, damage such as this may occur.Further evaluation of the device revealed that the pusher assembly was kinked near its proximal end and the introducer sheath was loaded backward on the device.This damage was likely incidental to the complaint and may have occurred after the procedure and during return to penumbra.Due to the pusher assembly kink, the device was unable to be re-sheathed properly into its introducer sheath and functional testing could not be performed.Therefore, the root cause of the complaint could not be determined.Evaluation of the returned pc400 revealed a kink in the pusher assembly.If the device is forcefully advanced against resistance or is otherwise mishandled at extreme angles during use, damage such as this may occur.During functional testing, the pc400 was able to advance through the returned px slim with resistance due to the kink in the pusher assembly.The root cause of resistance during the procedure could not be determined.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: 3005168196-2021-01280 h3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11962840
• Report Number: 3005168196-2021-01281
• Device Sequence Number: 1376818
• Product Code: HCG
• UDI-Device Identifier: 00814548019369
• UDI-Public: 00814548019369
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021
• 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 Model Number: 4002C2060-A
• Device Catalogue Number: 4002C2060
• Device Lot Number: F96362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005