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

Model Number 400SMTXSFT0101

Device Problems Physical Resistance/Sticking (4012); Separation Problem (4043)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

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.This report is associated with mfr report number: 3005168196-2020-02263.

Event Description

The patient was undergoing coil embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target location; however, decided to reposition the smart coil.While retracting the smart coil, the physician experienced resistance and subsequently, the smart coil unintentionally detached.The physician then used the pusher assembly of the smart coil to successfully push the smart coil back into the aneurysm.Afterwards, the physician advanced another smart coil into the microcatheter.Then, to test the smart coil the physician advanced and retracted the smart coil several times in the proximal end of the microcatheter and the physician experienced resistance while retracting the smart coil.Subsequently, the smart coil unintentionally detached.The physician then used the pusher assembly of the smart coil to successfully push the smart coil back into the aneurysm.The procedure ended at this point.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: 10999086
• MDR Text Key: 226000094
• Report Number: 3005168196-2020-02264
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• 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: 01/01/2005,11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Model Number: 400SMTXSFT0101
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F81198
• 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: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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: 43 YR