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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 INTRODUCER CATHETER

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ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET INTRODUCER CATHETER Back to Search Results
Model Number IPN000133
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer does not report a malfunction of the device. The customer reports that stent moved into the aorta due to a bad manipulation by the operator.
 
Event Description
It was reported that " 62 female patient during revascularization of the mesenteric artery. After placing the stent, the stent moved into the aorta due to a bad manupulation by operator. Then, catheter could not be removed through the sheath 5f. Doctor removed the entire sheath and replace it with a 6f in order to continue with the procedure. New endoprosthesis placed successfully in the mesenteric artery. Doctor try to recover the loose stent with a lasso through the right bracchial artery but the stent was stuck in the artery and the lasso got stuck in the endoprothesis. Clinical consequences : removal of entire cat-lab sheath introductor 5f in order to insert a 6f one.
 
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Brand NameARROW CATH-LAB SHEATH INTRO SET
Type of DeviceINTRODUCER CATHETER
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 Key9610498
MDR Text Key177228420
Report Number9680794-2020-00031
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K924607
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 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberIPN000133
Device Catalogue NumberCL-07590
Device Lot Number14F17M0212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2018
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: 01/21/2020 Patient Sequence Number: 1
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