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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN000072
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The reported complaint that the "guide wire gets stuck at the tip of the catheter" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
 
Event Description
It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.
 
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Brand Name
CATH PKGD: WEDGE 6 FR 110 CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
marling heaton
3015 carrington mill blvd
morrisville 27560
MDR Report Key15197821
MDR Text Key304892236
Report Number3010532612-2022-00310
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00801902002877
UDI-Public00801902002877
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date05/31/2023
Device Model NumberIPN000072
Device Catalogue NumberAI-07126
Device Lot Number16F22B0077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
Patient Age70 YR
Patient SexFemale
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