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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC INTRODUCER INTRODUCER, CATHETER

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MEDTRONIC, INC. MEDTRONIC INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number MDT-INTRODUCER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 02/02/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure the patient experienced pneumothorax.  the pneumothorax was treated with endothoracic drainage. Pulmonary expansion was achieved and the patient was stable. The suspected cause was the was iatrogenic during subclavian access with the introducer. No further patient complications have been reported as a result of this event.
 
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Brand NameMEDTRONIC INTRODUCER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14494598
MDR Text Key292570378
Report Number2182208-2022-01698
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMDT-INTRODUCER
Device Catalogue NumberMDT-INTRODUCER
Was Device Available for Evaluation? No
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/25/2022 Patient Sequence Number: 1
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