• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET CATHETER, INTRODUCER Back to Search Results
Catalog Number CL-07011
Device Problems Break (1069); Migration (4003)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 02/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the hub of the device snapping off. Intervention: a piece of the device was retrieved in the soft tissue/partially in the vessel of the patient. The patient was taken to the or for conscious sedation and local removal by the provider. No complications with removal. The patient was stable post procedure and later discharged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW CATH-LAB SHEATH INTRO SET
Type of DeviceCATHETER, INTRODUCER
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 Key8189770
MDR Text Key131178806
Report Number9680794-2018-00280
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Catalogue NumberCL-07011
Device Lot Number14F17J0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
-
-