MAUDE Adverse Event Report: PENUMBRA, INC PENUMBRA; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number 400SMTXSFT2H08

Device Problems Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2020

Event Type  malfunction  

Event Description

Coil would not deploy once in correct position, back end of coil frayed off.It was able to be retrieved.

• Brand Name: PENUMBRA
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC; one penumbra place; alameda CA 94502
• MDR Report Key: 9933067
• MDR Text Key: 186709571
• Report Number: 9933067
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2020,03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 400SMTXSFT2H08
• Device Lot Number: F90172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA