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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-07745
Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges the doctor found that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.A new set was used and the procedure was successfully completed.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one sheath/dilator assembly.Visual inspection was performed and no issues were identified.The outer diameter of the lower locking portion of the dilator hub was measured and did not meet specification.The inner diameter of the sheath valve cap was found to be within specification.The dilator hub would not snap into the sheath cap and required little force to be removed.A device history record (dhr) review was performed and no relevant findings were identified.The customer reported issue of the dilator and sheath not locking together was confirmed during the complaint investigation of the returned sample.The dilator hub would not fully snap into the sheath cap and required little force to be removed during functional testing.The outer diameter of the lower locking portion of the dilator hub measured out of tolerance during dimensional testing; therefore, the probable cause of this issue is manufacturing related.A capa was previously generated to further investigate this issue.
 
Event Description
The customer alleges the doctor found that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.A new set was used and the procedure was successfully completed.
 
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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
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
9194334854
MDR Report Key6830012
MDR Text Key83962672
Report Number9680794-2017-00165
Device Sequence Number1
Product Code DQY
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 distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue NumberCL-07745
Device Lot Number14F15K0191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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