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

Model Number 400SMTXSFT0406

Device Problems Device Contamination with Chemical or Other Material (2944); Activation Problem (4042)

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

Event Date 04/02/2019

Event Type  malfunction  

Event Description

Attempting first coil placement penumbra coil could not be deployed through the stryker catheter.Devices removed and a sticky debris noted on coil and catheter, penumbra rep took for analysis.

• Brand Name: SMART COIL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8577265
• MDR Text Key: 143955421
• Report Number: 8577265
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2019,04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTXSFT0406
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F86349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 68