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

Model Number 400SMTHXSFT0102

Device Problem Unintended Movement (3026)

Patient Problem Extravasation (1842)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Potential adverse events in the labeling with the penumbra smart coil include, but are not limited to, hematoma or hemorrhage at the site, device malfunction, thromboembolic episodes, 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

On (b)(6) 2020, the patient underwent a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating (acomm) artery using penumbra smart coils (smart coils), a non-penumbra microcatheter and balloon.During the procedure, the physician noticed that upon removal of the microcatheter and the balloon, there was a coil loop extravasation into the left a2.After multiple attempts, they were unable to catheterize.Intra-arterial aggrastat was administered due to small evidence of clot formation.The right internal carotid artery (ica) was then catheterized, followed by the acomm artery and the contralateral a2 past the aneurysm coil loop were catheterized.The angiography demonstrated the coil to be well seated in the aneurysm sac, and the parent vessel to be widely patent.The coil loop extravasation was resolved on the same day.The coil loop extravasation was reported to be a non-serious adverse event with a definite relationship to the smart coil and unrelated to the index 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: 11925214
• MDR Text Key: 254552551
• Report Number: 3005168196-2021-01220
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (y/n): Y
• 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: 01/01/2005,05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F99862
• 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: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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): Required Intervention
• Patient Age: 64 YR