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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-07724
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports: according to the ifu, the dilator tip part was split while the md was using device. The md did not use it, and he finished the procedure with teleflex's same product.

 
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Brand NameARROW CATH-LAB SHEATH INTRO SET
Type of DeviceCATHETER, 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 Key7293165
MDR Text Key101008835
Report Number9680794-2018-00042
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCL-07724
Device LOT Number14F16C0768
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated By Manufacturer? Yes
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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