MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL DETACHMENT HANDLE; HCG, KRD

Model Number SCH1

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

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: 3005168196-2021-02728.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the physician made several attempts and broke the pusher assembly to manually detach the smart coil.The procedure was completed using other coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned smart coil could not confirm the reported complaint due to the returned damage.Evaluation revealed that the pet lock was not present, the proximal end of the pusher assembly was fractured, and the embolization coil was detached from the pusher assembly.This damage was likely due to the manual coil detachment attempted during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed kinks throughout the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packing for the device return.Evaluation of the returned handle could not confirm the reported complaint.Evaluation revealed that the device was functional and undamaged.During functional testing, the handle was tested with a handle test fixture and functioned without issue.The handle was able to detach a demonstration smart coil without issue.Penumbra coils and handles are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 1.3005168196-2021-02729.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• Type of Device: 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: 12919706
• MDR Text Key: 286585111
• Report Number: 3005168196-2021-02729
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/06/2021

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
• Device Operator: Health Professional
• Device Model Number: SCH1
• Device Catalogue Number: SCH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male