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

Catalog Number 400SMTHXSFT0308

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2017-01793.The hospital disposed of the device.

Event Description

Upon removal of two penumbra smart coils (smart coils) from their dispenser hoops, the technologist inadvertently kinked the proximal portion of the pusher assemblies on both coils.The pusher assemblies became damaged prior to use in the patient and therefore, the smart coils were not used in the procedure.The procedure was successfully completed using new smart coils.

• 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: 6959172
• MDR Text Key: 90584872
• Report Number: 3005168196-2017-01794
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 00814548015798
• Combination Product (y/n): N
• 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: 09/19/2017

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: Radiologic Technologist
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F74320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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