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

Catalog Number 400SMTXSFT3H06

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

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 hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician placed a non-penumbra coil in the target vessel using a non-penumbra microcatheter.While placing a smart coil in the target vessel, approximately five millimeters of the proximal end of the smart coil stopped taking its intended shape; therefore, it was removed.The physician then successfully placed two other coils and a smart coil in the ica.While attempting to advance a non-penumbra coil into the microcatheter, the physician experienced resistance near the hub of the microcatheter.The physician then pushed the guidewire into the microcatheter with some resistance and the guidewire stopped approximately five centimeters from the distal tip of the microcatheter.Therefore, the physician removed the microcatheter and the guidewire altogether from the patient¿s body.Upon flushing the microcatheter, a red-colored foreign object that looked like thrombus came out of the microcatheter.The procedure was completed using another microcatheter and 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: 7631727
• MDR Text Key: 112417833
• Report Number: 3005168196-2018-01252
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/08/2022
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F79964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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