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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR CATHETER, INTRODUCER Back to Search Results
Catalog Number AK-09903-JJ
Device Problems Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the user found it difficult to insert a non-arrow catheter into the sheath after placement of the sheath. Therefore, the sheath was removed and replaced with a new one. No patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW PSI KIT: 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 Key13994571
MDR Text Key288672151
Report Number3006425876-2022-00283
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
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 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberAK-09903-JJ
Device Lot Number71F21F1827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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