13FR MECHANICAL DILATOR SHEATH SET LR-EVN-13.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-02 for 13FR MECHANICAL DILATOR SHEATH SET LR-EVN-13.0 manufactured by Cook Vascular Inc.

Event Text Entries

[4039392] Pt expired during procedure in cath lab. Physician had difficulty removing a lead with possible adhesion of lead to the superior vena cava. Resulted in what appeared to be...
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5033199
• MDR Report Key: 3499808
• Date Received: 2013-12-02
• Date of Report: 2013-11-27
• Date of Event: 2013-11-18
• Date Added to Maude: 2013-12-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: 13FR MECHANICAL DILATOR SHEATH SET
• Generic Name: 13FR MECHANICAL DILATOR SHEATH SET
• Product Code: DRE
• Date Received: 2013-12-02
• Catalog Number: LR-EVN-13.0
• Lot Number: N100925
• Device Expiration Date: 2014-08-01
• Operator: HEALTH PROFESSIONAL
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK VASCULAR INC
• Manufacturer Address: VADERGRIFT IL 15690 US 15690

Device Sequence Number: 2

• Brand Name: LOCKING STYLET
• Generic Name: LOCKING STYLET
• Product Code: DQX
• Date Received: 2013-12-02
• Catalog Number: LR-OFA01
• Lot Number: N104285
• Operator: HEALTH PROFESSIONAL
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOK VASCULAR INC
• Manufacturer Address: VADERGRIFT IL 15690 US 15690

Device Sequence Number: 3

• Brand Name: ONE-TIE COMPRESSION COIL
• Generic Name: ONE-TIE COMPRESSION COIL
• Product Code: HYA
• Date Received: 2013-12-02
• Catalog Number: LR-OTE-N
• Lot Number: N111634
• Operator: HEALTH PROFESSIONAL
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COOK VASCULAR INC
• Manufacturer Address: VADERGRIFT IL 15690 US 15690

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2013-12-02