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

Catalog Number 400SMTSTD1360

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the cavernous segment of the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached a smart coil into the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and decided to remove the coil; however, upon retraction, the smart coil unintentionally detached.Therefore, the physician used the smart coil pusher assembly to push the detached coil out of the microcatheter and into the aneurysm.The procedure was completed using additional coils.There was no report of an adverse effect to the patient.

• 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: 7154731
• MDR Text Key: 96112750
• Report Number: 3005168196-2017-02316
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014265
• UDI-Public: 00814548014265
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 400SMTSTD1360
• Device Lot Number: F76888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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: 78 YR