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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR CATHETER, INTRODUCER

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ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR CATHETER, INTRODUCER Back to Search Results
Catalog Number AD-09903
Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/21/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported after successful puncture in the right subclavian, the spring wire guide was inserted and when attempting to remove the needle, the needle got hooked on the wire. When the wire was pulled back, the wire was unraveled "and even torn off", so that part of the wire remained in the patient. It was reported the wire was identified by x-ray and was completely removed by vascular surgery. The patient was reported to be doing well following removal.
 
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Brand NameARROW PSI SET: 9 FR
Type of DeviceCATHETER, INTRODUCER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key15285668
MDR Text Key298517471
Report Number3006425876-2022-00766
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAD-09903
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
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: 08/24/2022 Patient Sequence Number: 1
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