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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL LLC PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN056907
Device Problems Entrapment of Device (1212); Material Too Rigid or Stiff (1544)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 06/09/2023
Event Type  malfunction  
Event Description
It was reported that: a localized superficial venous thrombosis formed in the basilic vein when the guide was being advanced under echo and got stuck, during use on the patient.They felt that the guide was very rigid.On removal there was no reported damage to the guide.There was no additional surgical intervention performed and no other symptoms.The patient was reported as stable throughout with no negative consequences other than increased procedure time.Associated to 3006425876-2023-00630 and 3006425876-2023-00628.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: a localized superficial venous thrombosis formed in the basilic vein when the guide was being advanced under echo and got stuck, during use on the patient.They felt that the guide was very rigid.On removal there was no reported damage to the guide.There was no additional surgical intervention performed and no other symptoms.The patient was reported as stable throughout with no negative consequences other than increased procedure time.Associated to 3006425876-2023-00630 and 3006425876-2023-00628.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "if placement damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the ifu also contains the cautions: "clinicians must be aware of the potential for entrapment of guidewire by any implanted device in circulatory system.It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to reduce risk of guidewire entrapment" and "sufficient guidewire length must remain exposed at hub end of sheath to maintain a firm grip on guidewire." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
PI MIDLINE 1-L: 4FR X 20CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17287484
MDR Text Key318697981
Report Number3006425876-2023-00629
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN056907
Device Catalogue NumberEU-32041
Device Lot Number71F23D0360
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/15/2023
Initial Date FDA Received07/10/2023
Supplement Dates Manufacturer Received08/01/2023
Supplement Dates FDA Received08/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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