PENUMBRA SMART COIL 400SMTXSFT2H06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PENUMBRA SMART COIL 400SMTXSFT2H06 manufactured by Penumbra, Inc..

Event Text Entries

[188347430] 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. This report is associated with mfr report numbers: 1. 3005168196-2020-00470, 2. 3005168196-2020-00471.
Patient Sequence No: 1, Text Type: N, H10

[188347431] The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter and a non-penumbra stent device. During the procedure, the physician used the stent device to hold open the vessel, then, the smart coil was successfully implanted into the target vessel using the handle and microcatheter. While advancing the next smart coil through the microcatheter, the physician encountered resistance but was able to reach the target location. After making an attempt to detach the smart coil using the handle, the physician was unsure whether it detached or not, and made an attempt to manually detach it. The physician was still unsure whether the smart coil truly detached; therefore, it was withdrawn. Upon removal of the pusher assembly, the physician realized that the smart coil had detached in the microcatheter; therefore, it was completely removed. The next smart coil was advanced approximately 10 centimeters into the same microcatheter and became stuck. The physician suspected that the microcatheter was occluded and decided to remove the smart coil and flush the microcatheter on the back table. While flushing the microcatheter, a small residue covered in blood emerged. Subsequently, the same microcatheter was re-advanced into the target vessel. While advancing the next smart coil through the microcatheter, the physician encountered resistance and upon removal, noticed that the pusher assembly had kinked in a "wave" form. The smart coil was discarded. Upon further analysis, the pusher assembly of all three complaint coils exhibited the same kinking. The procedure was completed using another smart coil, the same handle, the same microcatheter, and the same stent device. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3005168196-2020-00469
• MDR Report Key: 9908084
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-31
• Date of Report: 2020-03-05
• Date of Event: 2020-03-05
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-03-05
• Date Added to Maude: 2020-03-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. VERONICA FARRIS
• Manufacturer Street: ONE PENUMBRA PLACE
• Manufacturer City: ALAMEDA CA 94502
• Manufacturer Country: US
• Manufacturer Postal: 94502
• Manufacturer Phone: 5107483200
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PENUMBRA SMART COIL
• Generic Name: HCG, KRD
• Product Code: HCG
• Date Received: 2020-03-31
• Model Number: 400SMTXSFT2H06
• Catalog Number: 400SMTXSFT2H06
• Lot Number: F82132
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PENUMBRA, INC.
• Manufacturer Address: ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-31
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-31