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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; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CL-07645
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: md was performing the procedure according to ifu.However, during the procedure, air was continuously found in the sheath.Md removed the sheath from the patient's body.Since then, md has been proceeding with its own products, and the procedure has been completed without any abnormality.
 
Manufacturer Narrative
(b)(4).The customer returned one 6fr psi sheath/dilator assembly for evaluation.The sheath was returned with the sidearm stopcock in the open position.No defects or anomalies were identified.Functional inspection was performed per (b)(4), which references bs en iso 11070 for testing criteria.The amrq states that "there shall be no leakage past the hemostasis valve when test using a pressure of 3 psi".The returned psi sheath was connected to a leak tester and the distal tip of the sheath was occluded.The sheath was tested at 3 psi and no leaks were observed.The amrq also states that the test criteria for the sidearm assembly are "using a test pressure of 43.5 - 46.4 psi there shall be no leakage sufficient to form a falling drop." the sheath was tested at 45 psi and no leaks were observed.A device history record review was performed and no relevant findings were identified.The customer reported issue of the psi sheath leaking was not confirmed during the complaint investigation.Visual and functional inspections were performed on the returned psi sheath and no issues were identified.A device history record review was performed and no issues were identified.No issues were found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports: md was performing the procedure according to ifu.However, during the procedure, air was continuously found in the sheath.Md removed the sheath from the patient's body.Since then, md has been proceeding with its own products, and the procedure has been completed without any abnormality.
 
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Brand Name
ARROW CATH-LAB SHEATH INTRO SET
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7609617
MDR Text Key111433725
Report Number9680794-2018-00137
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue NumberCL-07645
Device Lot Number14F17B0119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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