TPLC - Total Product Life Cycle

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Device	catheter, recording, electrode, reprocessed
Definition	Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product Code	NLH
Regulation Number	870.1220
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASCENT HEALTHCARE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
INNOVATIVE HEALTH
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	3
INNOVATIVE HEALTH, LLC.
	SUBSTANTIALLY EQUIVALENT	20
STERILMED, INC.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	4
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	49	49
Material Deformation	43	43
Use of Device Problem	28	28
Break	18	18
Kinked	18	18
Defective Device	17	17
Positioning Problem	12	12
Inadequacy of Device Shape and/or Size	11	11
Device Operates Differently Than Expected	11	11
Difficult to Remove	10	10
Mechanical Jam	9	9
Patient Device Interaction Problem	9	9
Bent	8	8
Material Separation	7	7
Entrapment of Device	7	7
Signal Artifact/Noise	7	7
Positioning Failure	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Packaging Problem	5	5
Insufficient Information	5	5
Material Integrity Problem	5	5
Fracture	4	4
Material Twisted/Bent	4	4
Difficult To Position	4	4
Device Reprocessing Problem	4	4
Device Inoperable	4	4
Device Damaged Prior to Use	3	3
Knotted	3	3
Tear, Rip or Hole in Device Packaging	3	3
Noise, Audible	3	3
Difficult or Delayed Positioning	2	2
No Display/Image	2	2
Contamination /Decontamination Problem	2	2
Out-Of-Box Failure	2	2
Structural Problem	2	2
Device Sensing Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Activation, Positioning or Separation Problem	2	2
Shipping Damage or Problem	2	2
Material Too Rigid or Stiff	1	1
Device Packaging Compromised	1	1
Failure to Advance	1	1
Coiled	1	1
Difficult to Insert	1	1
Stretched	1	1
No Device Output	1	1
Failure to Disconnect	1	1
Device Displays Incorrect Message	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	99	99
No Consequences Or Impact To Patient	81	81
No Known Impact Or Consequence To Patient	64	64
Insufficient Information	11	11
Cardiac Tamponade	8	8
Pericardial Effusion	6	6
No Patient Involvement	5	5
No Information	4	4
Cardiac Perforation	3	3
Low Blood Pressure/ Hypotension	3	3
Arrhythmia	2	2
No Code Available	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Vascular Dissection	1	1
Perforation	1	1
Rupture	1	1
Atrial Fibrillation	1	1
Anemia	1	1
Foreign Body In Patient	1	1
Nerve Damage	1	1
Chest Pain	1	1
Cough	1	1
Tissue Damage	1	1
Tricuspid Regurgitation	1	1
Loss of consciousness	1	1
Thrombus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sterilmed Inc	II	Jan-13-2009
2	Stryker Sustainability Solutions	II	Jul-03-2024
3	Stryker Sustainability Solutions	II	Jan-23-2019
4	Stryker Sustainability Solutions	II	Nov-14-2018
5	Stryker Sustainability Solutions	II	Jul-12-2018
6	Stryker Sustainability Solutions	II	Mar-06-2018
7	Stryker Sustainability Solutions	II	Jan-07-2017
8	Stryker Sustainability Solutions	II	Nov-09-2016
9	Stryker Sustainability Solutions	II	May-23-2016
10	Stryker Sustainability Solutions	II	Nov-18-2013