MAUDE MDR 357329

MDR report key: 357329
Report number: 1062385-2001-00015
Event key: 0
Event type: 3
Date of event: 2001-09-28
Date received: 2001-10-17
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: ADAM LOWE, VP
Address: 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US
Phone: 770-770-7707
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	40MM BETA-CATH DELIVERY CATHETER	CATHETER	NOVOSTE CORPORATION	MOU	510609-040	BCK-0140	444111			N	R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-10-17	0

Event Narratives#

D

Patient 1

COMPLAINANT REPORTED THAT THE SEAMS OF THE STERILE BAG PROVIDED WITH THE BETA-CATH CATHETER SPLIT READILY WHEN UNFOLDING THE END OF THE BAG, AND THAT THE WHITE TAPE STRIP WAS LOCATED IN THE OPPOSITE/REVERSE LOCATION FROM WHERE IT USUALLY IS.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
M097PAP00351	Procedure Accessory Pack, 3.5F Coronary System, 5-Pack	BEST VASCULAR, INC.	MOU	2016-06-22
M0975301770020	Accessories Kit	BEST VASCULAR, INC.	MOU	2015-09-10
M097ABR03460	B-Rail 3.5F Delivery Catheter	BEST VASCULAR, INC.	MOU	2015-09-10
M097BRX03460	B-Rail 3.5F XL Delivery Catheter	BEST VASCULAR, INC.	MOU	2015-09-10
M097MPK00021	Medical Physicist Kit	BEST VASCULAR, INC.	MOU	2015-09-10
M097PAP00350	Procedure Accessory Pack	BEST VASCULAR, INC.	MOU	2015-09-10
M097RSK00020	Novoste Response Kit	BEST VASCULAR, INC.	MOU	2015-09-10
M097TDA20300	Alpha VI 30mm Transfer Device	BEST VASCULAR, INC.	MOU	2015-09-10
M097TDA20400	Alpha VI 40mm Transfer Device	BEST VASCULAR, INC.	MOU	2015-09-10
M097TDA20600	Alpha VI 60mm Transfer Device	BEST VASCULAR, INC.	MOU	2015-09-10
M097TRC00020	Twin Transport Case	BEST VASCULAR, INC.	MOU	2015-09-10
M097TSC00010	Temporary Storage Container	BEST VASCULAR, INC.	MOU	2015-09-10

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P000018S051	MOU	Novoste™ Beta-Cath™ System	Best Vascular, Inc.	2024-09-26
PMA	P000018S050	MOU	Beta-Cath System	Best Vascular, Inc.	2019-09-19
PMA	P000018S048	MOU	NOVOSTE BETA-CATH SYSTEM	Best Vascular, Inc.	2017-07-13
PMA	P000018S046	MOU	NOVOSTE BETA-CATH SYSTEM	Best Vascular, Inc.	2016-10-06
PMA	P000018S047	MOU	BETA-CATH (TM) SYSTEM	Best Vascular, Inc.	2016-07-26

MAUDE MDR 357329

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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