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

Catalog Number 400SMTSFT0410

Device Problems Migration (4003); Difficult or Delayed Separation (4044)

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

Event Date 09/04/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in anterior communicating artery (acomm) aneurysm using penumbra smart coils (smart coil), penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a non-penumbra balloon catheter.During the procedure, the physician advanced a balloon catheter past the aneurysm and then placed the microcatheter in the acomm aneurysm.Next, the physician advanced a smart coil into the target location and attempted to detach it using a handle; however, the smart coil failed to detach.After making three attempts to detach the smart coil using the handle, the physician attempted to manually detach the coil, but the attempt was unsuccessful.Therefore, the physician decided to remove the smart coil.However, while retracting the smart coil, the coil unintentionally detached inside the microcatheter.Subsequently, when the physician was removing the microcatheter containing the detached smart coil, the coil migrated out of the microcatheter and into the contralateral anterior cerebral artery (aca).Therefore, the physician advanced a non-penumbra catheter past the smart coil and then a stent retriever was used to remove the detached smart coil.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

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.Placeholder.

• 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: 15513728
• MDR Text Key: 303165244
• Report Number: 3005168196-2022-00458
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 0814548015095
• 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
• Report Date: 01/01/2005,09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400SMTSFT0410
• 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
• Date Manufacturer Received: 09/07/2022
• 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