Cardiac Ablation Percutaneous Catheter

Device Code: 1009

Product Code(s): LPB

Definition: This Product Code Pertains To Cardiac Ablation Catheters Indicated For General Indications, Treatment Of Supraventricular Tachycardia (svt) And Ventricular Tachycardia (vt). This Product Code Excludes Ablation Catheters Indicated For Treatment Of Atr

Device Classification Information

• Device Type ID: 1009
• Device Name: Cardiac Ablation Percutaneous Catheter
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Electrophysiology Devices Branch (CEDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LPB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1009
• Device: Cardiac Ablation Percutaneous Catheter
• Product Code: LPB
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	988
Material Puncture / Hole	107
Appropriate Term/Code Not Available	103
Device Contamination With Chemical Or Other Material	86
Coagulation In Device Or Device Ingredient	78
Device Operates Differently Than Expected	51
Device Displays Incorrect Message	50
Hole In Material	50
Insufficient Information	49
Break	38
Catheter	38
Temperature Problem	34
Signal Artifact	31
Device Issue	26
Crack	21
No Display / Image	21
Tip	19
Material Split, Cut Or Torn	18
Sharp Edges	18
Charred	17
High Impedance	16
Device Remains Activated	15
Positioning Problem	15
Shaft	14
Bent	14
Entrapment Of Device	13
Scratched Material	12
Noise, Audible	11
Sticking	11
Contamination / Decontamination Problem	11
Material Protrusion / Extrusion	10
Detachment Of Device Or Device Component	9
Human-Device Interface Problem	9
Device Sensing Problem	9
Material Integrity Problem	9
High Sensing Threshold	8
Fracture	8
Material Separation	8
Mechanical Jam	7
Device Alarm System	7
Device Contamination With Body Fluid	7
Tear, Rip Or Hole In Device Packaging	7
Delivered As Unsterile Product	7
Material Frayed	7
High Readings	6
Sensor	6
Impedance Problem	6
Housing	5
Torn Material	5
Ring	5
Material Deformation	5
Wire	5
Difficult To Remove	5
Failure To Sense	5
Device Operational Issue	5
Physical Resistance	5
Failure To Read Input Signal	4
Foot Pedal	4
Device Dislodged Or Dislocated	4
Peeled / Delaminated	4
Protective Measures Problem	4
Device Packaging Compromised	4
Overheating Of Device	4
Difficult To Position	4
Restricted Flow Rate	4
Kinked	3
Moisture Damage	3
Device Expiration Issue	3
Cut In Material	3
Device Damaged By Another Device	3
Radio Signal Problem	3
Air Leak	3
Pressure Problem	3
Image Display Error / Artifact	3
No Apparent Adverse Event	3
Loss Of Or Failure To Bond	3
Deflation Problem	3
Connection Problem	3
Improper Or Incorrect Procedure Or Method	3
Over-Sensing	3
Fail-Safe Did Not Operate	3
Infusion Or Flow Problem	3
Communication Or Transmission Problem	3
Material Twisted / Bent	2
Unintended Electrical Shock	2
Patient-Device Incompatibility	2
Expiration Date Error	2
Inflation Problem	2
Device Inoperable	2
Power Problem	2
Self-Activation Or Keying	2
Intermittent Continuity	2
Degraded	2
Physical Property Issue	2
Therapeutic Or Diagnostic Output Failure	2
Obstruction Of Flow	2
Detachment Of Device Component	2
Leak / Splash	2
Dent In Material	2
Biological Environmental Factor	2
Total Device Problems	2274

Recalls
Manufacturer		Recall Class	Date Posted
1	Biosense Webster, Inc.	II	Dec-07-2017
2	Biosense Webster, Inc.	II	Oct-27-2017
3	Biosense Webster, Inc.	II	Oct-27-2014
4	Medtronic Inc. Cardiac Rhythm Disease Management	II	Sep-17-2015

TPLC Last Update: 2019-04-02 19:46:19