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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) PEEL-AWAY INTRODUCER KIT 7F, .038, 14CM SHEATH
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ST. JUDE MEDICAL, INC. (AF-MINNETONKA) PEEL-AWAY INTRODUCER KIT 7F, .038, 14CM SHEATH Back to Search Results
Model Number 405108
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2014
Event Type  Injury  
Event Description
During a pacemaker implant procedure using a peel away introducer, a portion of the introducer detached and remained in the patient's vasculature.After implantation of the right ventricular pacing lead, a 7cm portion of the peel away introducer became detached and remained in the vasculature.A snare device was used to remove the introducer fragment.There were no adverse consequences for the patient.
 
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Brand Name
PEEL-AWAY INTRODUCER KIT 7F, .038, 14CM SHEATH
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
minnetonka MN
Manufacturer Contact
denise johnson, rn
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key3812498
MDR Text Key4529014
Report Number3005188751-2014-00071
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K791129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number405108
Device Lot Number4400763
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ASSURITY PACEMAKER, (PM2240/2932806); OPTISENSE PACING LEAD, (199-52/CWK054688); TENDRIL STS PACING LEAD, (2088TC-58/(B)(4)); TENDRIL STS PACING LEAD, (2088TC-58/(B)(4))
Patient Outcome(s) Required Intervention;
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