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

Catalog Number	4002C1145
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal carotid artery (ica) using penumbra coil 400s (pc400), a px slim delivery microcatheter (px slim), and non-penumbra coils.During the procedure, the physician successfully implanted two non-penumbra coils into the first aneurysm using the px slim.Next, the physician successfully implanted one pc400 into the second aneurysm using the px slim.Subsequently, while advancing a second pc400 through the px slim, the pc400 unintentionally detached.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using another pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pc 400 confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pusher assembly was fractured, and the pull wire was retracted out of the ddt.If the pusher assembly is advanced at an extreme angle during use, damage such as a kink and subsequent fracture may occur.This fracture likely contributed to the embolization coil detaching from its pusher assembly during the procedure.Further evaluation revealed pusher assembly kinks.This damage was incidental to the reported complaint and the root cause could not be determined.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.

• 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: 15351078
• Report Number: 3005168196-2022-00406
• Device Sequence Number: 20345903
• Product Code: HCG
• UDI-Device Identifier: 00814548010625
• UDI-Public: 814548010625
• 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): 11/14/2022
• 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 Catalogue Number: 4002C1145
• Device Lot Number: F105256
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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: 62 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005