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

Model Number 400SMTSFT0610

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Box 6.Device code (b)(4) the device problem "smart coil pushing back" is not adequately defined by another code.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) and posterior communicating artery (pcom) using penumbra smart coils.During the procedure, a smart coil pushed back.The procedure was completed using four more smart coils.Post-procedure, the patient was dosed with brilinta.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2020-00988.4.Section h.Box 6.Method code 1, method code 2 & method code 3.5.Section h.Box 6.Results code 1.6.Section h.Box 6.Conclusions code 1.Please note that the following sections are being updated based on additional information provided by a penumbra representative on 12/02/2020: 1.Section b.Box 5.Describe event or problem.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) and posterior communicating artery (pcom) using penumbra smart coils.During the procedure, a loop of first smart coil was pushed back into the artery during the placement of second smart coil.The procedure was completed using four more smart coils.Post-procedure, the patient was dosed with brilinta.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
• MDR Report Key: 10311736
• MDR Text Key: 199980572
• Report Number: 3005168196-2020-00988
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: 400SMTSFT0610
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: C19737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR