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

Catalog Number 400SMTXSFT2H03

Device Problem Separation Failure (2547)

Patient Problem Ruptured Aneurysm (4436)

Event Date 11/07/2021

Event Type  Injury  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization to treat an aneurysm using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil; however, it would not detach.Therefore, the smart coil was removed.It was reported that the aneurysm ruptured while the physician attempted to detach the smart coil.There is a possible relationship between the aneurysm rupture and the use of the smart coil.The procedure was completed using another smart coil and the same microcatheter.It was also reported that the patient later expired.The patient¿s cause of death is unknown.

Event Description

The patient was undergoing a coil embolization in the posterior inferior cerebellar artery (pica) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil; however, it would not detach.Therefore, the physician decided to remove the smart coil.While retracting the smart coil, the microcatheter kicked forward and subsequently, the aneurysm ruptured.There is a possible relationship between the aneurysm rupture and the use of the smart coil.The procedure was completed using additional smart coils, the same handle, and the same microcatheter.It was also reported that the patient later expired.The patient¿s cause of death is unknown.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by the sales representative on 19-feb-2022: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the penumbra smart coil system instructions for use (ifu) include, but are not limited to aneurysm rupture, hematoma or hemorrhage at access site of entry, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 13112139
• MDR Text Key: 282921208
• Report Number: 3005168196-2021-02801
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/04/2022

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
• Device Catalogue Number: 400SMTXSFT2H03
• 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: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/19/2022
• Supplement Dates FDA Received: 03/04/2022
• 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
• Patient Age: 91 YR
• Patient Sex: Female