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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER
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TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER Back to Search Results
Model Number IPN921746
Patient Problem Hematoma (1884)
Event Date 08/19/2023
Event Type  malfunction  
Event Description
While the arterial line was being placed, resistance was encountered as the guidewire was inserted.The guidewire then could not be removed.Thus, both the needle and guidewire ended up being removed as a unit, which likely contributed to the hematoma.Once out of the body, the resident noticed that the tip of the guidewire appeared frayed.Eventually they separated the guidewire and the needle apparatus, at which point the guidewire tip had unraveled and more extensively frayed.It was described as having an appearance of a spiral cat toy.Manufacturer response for wire, guide, catheter, arrow (per site reporter).Device was returned to the manufacturer.
 
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Brand Name
ARROW
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key17763791
MDR Text Key323591283
Report Number17763791
Device Sequence Number1
Product Code DQX
UDI-Device Identifier10801902200447
UDI-Public(01)10801902200447
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN921746
Device Catalogue NumberASK-04120-HF3
Device Lot Number33F23E0480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2023
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer09/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age19345 DA
Patient SexMale
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