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

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Perforation of Vessels (2135)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, hematoma or hemorrhage at access site of entry, ischemia, vessel spasm, thrombosis, dissection, or perforation, including death.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2021-02169, 3005168196-2021-02171.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil into the target location and attempted to detach it using the handle; however, the smart coil failed to detach.Subsequently, the physician used force to manually detach the smart coil in the target location.Afterwards, while advancing another smart coil into the target location, the physician noticed that the last two-three millimeters of the smart coil was very stiff and would not advance into the aneurysm sac.Subsequently, the smart coil kicked back and punctured the wall of the aneurysm.It was reported that there was a balloon catheter already in place that prevented further injury.After that, the physician attempted to detach the smart coil using the handle; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil into the aneurysm sac.No additional information has been provided regarding the completion of the procedure.

• Brand Name: PENUMBRA SMART COIL
• 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: 12565765
• MDR Text Key: 274454966
• Report Number: 3005168196-2021-02170
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 09/08/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other