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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIZONA DEVICE MFG SAFE SHEATH INTRODUCER, CATHETER

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ARIZONA DEVICE MFG SAFE SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number HLS1007M
Device Problem Break (1069)
Patient Problem Pneumothorax (2012)
Event Date 08/21/2020
Event Type  malfunction  
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 "slight" pneumothorax. The introducer sheath exhibited a puncture and leaked air. The sheath was attempted not used and replaced. No further patient complications have been reported as a result of this event.
 
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Brand NameSAFE SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ARIZONA DEVICE MFG
2343 w medtronic way
tempe AZ 85281
Manufacturer (Section G)
ARIZONA DEVICE MFG
2343 w medtronic way
tempe AZ 85281
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10526833
MDR Text Key207750881
Report Number2032545-2020-00001
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
OEM-RESP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLS1007M
Device Catalogue NumberHLS1007M
Device Lot NumberQ1689488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/24/2019
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: 09/14/2020 Patient Sequence Number: 1
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