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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET: INTRODUCER, CATHETER

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ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET: INTRODUCER, CATHETER Back to Search Results
Catalog Number CP-07811
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During the procedure the physician found that the dilator was not inserted into the sheath. The device was replaced. No patient harm. The patient's condition is reported as fine.
 
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Brand NameARROW CATH-LAB SHEATH INTRO SET:
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key13418522
MDR Text Key286069229
Report Number9680794-2022-00062
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCP-07811
Device Lot Number14F20G0046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2020
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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