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

Catalog Number	4002C0925
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
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 anterior communicating artery (acom) using penumbra coil 400s (pc400) and a microcatheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing a pc400 through the microcatheter and subsequently, the pc400 unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pc400 was removed.It was reported that the same issue occurred with another pc400; therefore, the microcatheter containing the detached pc400 was removed as well.The procedure was completed using a new pc400 and the same microcatheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra coil 400s (pc400) and a px slim delivery microcatheter (px slim).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing a pc400 through the px slim and subsequently, the pc400 unintentionally detached within the px slim.Therefore, the px slim containing the detached pc400 was removed.It was reported that the same issue occurred with another pc400; therefore, the px slim containing the detached pc400 was removed as well.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 3/28/2023: 1.Section b.Box 5.Describe event or problem: evaluation of the returned pc400 pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the pull wire was retracted out of its initial position and extended distal to the pusher assembly distal tip.If the pc400 is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, and the embolization coil may detach from the pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation revealed a fracture near the proximal end of the pusher assembly and kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and likely occurred during packaging for return to penumbra.Evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the sr component was fractured, and the embolization coil had offset coil winds and the introducer sheath was kinked near its distal tip.If the introducer sheath is mishandled at an extreme angle, damage such as a kink may occur.This damage likely contributed to the resistance during advancement.Forceful manipulation against this resistance likely contributed to the sr component fracture and offset coil winds on the embolization coil.If the sr component is fractured, the embolization coil may detach from the pusher assembly.Further evaluation revealed kinks on the pusher assembly.This damage was incidental to the reported complaint.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.This report is associated with mfr report numbers: 1.3005168196-2023-00049.

• 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: 16264085
• Report Number: 3005168196-2023-00050
• Device Sequence Number: 11858593
• Product Code: HCG
• UDI-Device Identifier: 00814548010571
• UDI-Public: 814548010571
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023
• 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: 4002C0925
• Device Lot Number: F110896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: Male
• Date Report Sent to FDA: 01/01/2005