PEEL-AWAY INTRODUCER, DI-LOCK, 7F, 14, CM, .038 405153

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for PEEL-AWAY INTRODUCER, DI-LOCK, 7F, 14, CM, .038 405153 manufactured by St. Jude Medical.

Event Text Entries

[186597528] The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[186597529] Related manufacturer reference number: 3005334138-2020-00124. During a crt-d implant procedure, the subclavian vein was perforated. When access to the subclavian vein was being performed, several punctures were required but were not successful. The vein was perforated several times and the patient's condition worsened with blood noted to be coming from the mouth. The patient was intubated and required ventilation support, eventually being transferred to the surgical operating room in unstable condition. Open chest surgery was required to stop the bleeding. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005334138-2020-00123
MDR Report Key9884928
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-03-07
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEEL-AWAY INTRODUCER, DI-LOCK, 7F, 14, CM, .038
Generic NameINTRODUCER, CATHETER
Product CodeDYB
Date Received2020-03-26
Model Number405153
Catalog Number405153
Lot Number6892206
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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