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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-07524
Device Problems Break (1069); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.The upper part of the dilator broke.A new set was used and the procedure was completed successfully.
 
Manufacturer Narrative
Qn#: (b)(4).The customer returned one sheath/dilator assembly for evaluation.A visual inspection was performed and no defects were identified.The inner diameter of the hemostasis valve cap was measured and was found to be within specification.The outer diameter of the dilator hub that locks into the hemostasis valve cap was found to be out of specification.The dilator did not lock into the 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 not locking into the psi sheath was confirmed during the sample investigation.Functional inspection was performed and the dilator was confirmed to not lock in place.Dimensional inspection determined that the cause of the issue was the dilator hub outer diameter being undersized.The probable cause of this issue is manufacturing related.A capa has been initiated to further investigate this issue.
 
Event Description
The customer alleges that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.The upper part of the dilator broke.A new set was used and the procedure was completed successfully.
 
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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 Key6992847
MDR Text Key91364210
Report Number9680794-2017-00240
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 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberCL-07524
Device Lot Number14F16B0198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2016
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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