MAUDE MDR 9392059

MDR report key: 9392059
Report number: 2134265-2019-14695
Event key: 0
Event type: 3
Date of event: 2019-11-19
Date received: 2019-11-29
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: JAY JOHNSON
Address: TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone: 763-763-7634
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	COYOTE ES	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	BOSTON SCIENTIFIC CORPORATION	LIT	24691	24691	0023230208				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
08033477048772	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048802	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048833	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048864	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048888	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048925	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048956	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048987	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049014	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049045	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049069	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049076	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049106	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049137	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049168	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049199	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049212	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049229	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049250	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049281	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049311	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049373	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049434	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049397	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477049090	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048727	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048734	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048765	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048796	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19
08033477048819	REEF HP	MEDTRONIC, INC.	LIT	2016-06-19

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K260304	LIT	WAVE PTA Balloon Catheter	WAVE Medical AG	2026-05-20
510(k)	K252512	LIT	Armada™ 14 NC PTA Catheter	ABBOTT MEDICAL	2026-02-13
510(k)	K251915	LIT	Amethyst HP PTA OTW 0.035 Catheter	Natec Medical , Ltd.	2025-12-18
510(k)	K250706	LIT	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	Biotronik, Inc.	2025-04-04
510(k)	K243704	LIT	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2025-02-27
PMA	P950020S010	LIT	FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)	Boston Scientific Corp	2005-07-18
PMA	P950020S012	LIT	ULTRA2 CUTTING BALLOON MONORAIL(MR)	Boston Scientific Corp	2005-03-16
PMA	P950020S011	LIT	CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)	Boston Scientific Corp	2005-03-08

MAUDE MDR 9392059

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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Related PMN/PMA Records By Product Code#