Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; INTRODUCER CATHETER
  • 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; 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.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and one possible relevant finding was found for wire spacing.It cannot be confirmed that this device had an issue with wire spacing without the sample.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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.
 
Manufacturer Narrative
(b)(4).The customer returned one sheath for evaluation.Visual examination did not reveal any defects or anomalies.The sheath body appeared smooth, uniform, and contained no obvious kinks or blockages.The inner diameter of the distal tip measured to be 0.073" which is within specifications of 0.072"-0.074" per product drawing.The inner diameter of the proximal end measured to be 0.075" which is greater than the minimum specification of 0.074" per product drawing.The total length of the sheath body measured to be 35" which is within specifications of 34.875"-35.875" per product drawing.Although the actual catheter was not returned for evaluation, a lab inventory 5fr catheter was able to advance and retract through the returned sheath with minimal resistance.A device history record review was performed with a potentially relevant finding.A non-conformance was created for wire spacing issues.However, this defect was not observed on the returned sample.The ifu provided with this kit warns the user, "do not apply excessive force in removing guide wire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary." the ifu also precautions the user, "do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage." the customer report of a non-arrow catheter tight in sheath could not be confirmed by complaint investigation of the returned sample.Although the actual catheter was not returned for analysis and the customer did not report what size catheter was used, a lab inventory 5fr catheter was able to pass through the returned sheath with minimal resistance.The sample passed all relevant visual, dimensional, and functional testing.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
 
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 manipulation 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 brachial artery but the stent was stuck in the artery and the lasso got stuck in the endoprosthesis.Clinical consequences : removal of entire cat-lab sheath introductor 5f in order to insert a 6f one.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CATH-LAB SHEATH INTRO SET
Type of Device
INTRODUCER CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9610498
MDR Text Key177228420
Report Number9680794-2020-00031
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K924607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Health Professional
Device Expiration Date11/30/2022
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
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
-
-