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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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TELEFLEX INCORPORATED ARROW; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number IPN036721
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
Upon withdrawing the guidewire from the quinton catheter, post insertion, the physician noted the tip was not "curved" as it normally is, but was "straight".The catheter was replaced the next day, and dialysis was performed via the catheter.3 days later, a metallic object was observed on the chest x-ray, located in the pulmonary artery.The patient was taken to interventional radiology, and the metallic object was successfully removed.The metallic object was found to be the tip of the guidewire which had migrated from the groin insertion site to the pulmonary artery.
 
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Brand Name
ARROW
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key8721591
MDR Text Key148779500
Report Number8721591
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN036721
Device Catalogue NumberCDC-25122-X1A
Device Lot Number23F18H0452
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/28/2019
Event Location Hospital
Date Report to Manufacturer06/21/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age14965 DA
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