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

Catalog Number 400SMTXSFT0206

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, it was reported that a smart coil was ¿defective¿.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device was initially available for return; however, additional information obtained confirmed that the device was discarded by the hospital.The report was therefore corrected accordingly.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.

• 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: 7033166
• MDR Text Key: 92936246
• Report Number: 3005168196-2017-01976
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F78436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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