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

Catalog Number SCH1

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-01043.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and two penumbra smart coil detachment handles (handles).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then advanced and attempted to detach a smart coil in the target location, however the smart coil did not detach, despite three attempts with the handle.The physician, therefore, attempted to detach the smart coil using a new handle, however the smart coil still did not detach.The smart coil was therefore removed, and the procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

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: 3005168196-2018-01043.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• 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: 7538790
• MDR Text Key: 109104787
• Report Number: 3005168196-2018-01042
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/23/2018

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: Physician
• Device Expiration Date: 12/13/2022
• Device Catalogue Number: SCH1
• Device Lot Number: F81012
• 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
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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