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

Catalog Number	4006C0406
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra coil 400s (pc400s), penumbra coil 400 detachment handles (handle), and a px slim delivery microcatheter (px slim).It was noted that the patient''s anatomy was tortuous.During the procedure, the physician implanted two pc400s using the handle.After advancing the third pc400 into the target location and making several attempts to detach the pc400 using the handle, the coil failed to detach.While retracting the pusher assembly of the pc400, the pc400 was pulled back into the px slim and subsequently unintentionally detached inside the px slim.The px slim containing the detached pc400 was removed from the patient, and the devices were no longer used in the procedure.The physician then advanced another pc400 into the target location using a new px slim and attempted to detach the coil using a second handle.After several attempts, the physician was able successfully detach the pc400.It was reported that one loop of the pc400 was extruding from the aneurysm; however, the physician does not believe it would result in any clinical consequence and no further action was taken.The procedure was completed using additional pc400s, the second handle, and the second px slim.There was no report of an adverse effect to the patient.
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: 1.3005168196-2023-00472 h3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the first returned pc400 confirmed that the embolization coil detached.Evaluation revealed that the embolization coil was detached inside the returned px slim, and the catheter was ovalized.This type of damage occurs if the pc400 is retracted against resistance, the pusher assembly may elongate beyond reach of the pull wire and the embolization coil will detach.The ovalization in the px slim likely contributed to resistance while retracting the pc400 into the catheter during the procedure.The pusher assembly was not returned for evaluation, and therefore, the root cause of the detachment issue could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage was incidental to the reported complaint and may have occurred during the procedure.Penumbra devices 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: 1.3005168196-2023-00472 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17972054
• Report Number: 3005168196-2023-00471
• Device Sequence Number: 20073232
• Product Code: HCG
• UDI-Device Identifier: 00814548018218
• UDI-Public: 814548018218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023
• 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 Catalogue Number: 4006C0406
• Device Lot Number: F00005967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005