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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 8F INTRODUCER, CATHETER

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GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 8F INTRODUCER, CATHETER Back to Search Results
Model Number 1000093-003
Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problems Arrhythmia (1721); Tachycardia (2095)
Event Date 03/11/2022
Event Type  Injury  
Event Description
Dr (b)(6) used peelable introducers model number 1000093-001 and 1000093-03 for a dual chamber icd placement. Dr (b)(6) placed both introducers into the blood vessel. He then began placing rv icd lead via model 1000093-03. While manipulating icd lead the introducer consistently kinked at the hub of where the peelable portion of the introducer met the wings where you peel. He had to manipulate the introducer while trying to position the lead. At one point he was unable to quickly maneuver the lead and pt had sustained vt which required an external defibrillation. He did state he should have maneuvered lead better to prevent vt, but said the introducer did make it more difficult.
 
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Brand NameOPTISEAL VALVED PTFE PEELABLE INTRODUCER 8F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
GREATBATCH MEDICAL
2300 berkshire lane
minneapolis MN 55441
Manufacturer Contact
samuel master
2300 berkshire lane
minneapolis, MN 55441
7639518115
MDR Report Key14167591
MDR Text Key289750929
Report Number2183787-2022-00023
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000093-003
Device Catalogue Number1000093-003
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2022
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 Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
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