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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY
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ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY Back to Search Results
Model Number IPN035902
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During a thrombectomy of a patient's loop graft, the user had done a few passes and noticed the basket was not fully opening up.When the device was removed from the patient, the catheter had come detached and started to slide up over the basket, not allowing the basket to fully open.The patient was not injured.A new catheter was opened to finish the procedure.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one 5 fr catheter for evaluation.Visual inspection of the catheter revealed that the sheath had completely separated from the juncture hub.No remains of the sheath were found in the juncture hub.The sheath was partially covering the basket when returned.The basket and tip were intact.Microscopic examination revealed that the separation point on the sheath was deformed and twisted.Part of the wiring supporting the sheath was broken and poking through the sheath.The total length of the catheter body measured 23.875", which is longer than the specifications of 22.9-23.1" per sheath extension assembly graphic.This confirms that the sheath was pulled from inside the juncture hub molding as well.The outer diameter of the catheter body measured 0.07095", which is within specifications of 0.069-0.071" per sheath extension assembly graphic.The ptd catheter was not able to be functionally tested due to the damage on the catheter body.Previously, manufacturing was contacted to identify a potential root cause for this failure mode.It was determined that the only way the failure was able to be recreated was through pulling directly on the sheath.The failure could not be recreated through normal process conditions.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not advance ptd catheter forward during activation." the complaint of a separated catheter was confirmed through a complaint investigation of the returned sample.The sheath of the ptd catheter was found to be completely separated from the juncture hub.The device met all dimensional requirements and a device history record review was performed, and no relevant findings were identified.Based on the device returned, and the feedback from manufacturing, user error - undue force likely caused this event.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
During a thrombectomy of a patient's loop graft, the user had done a few passes and noticed the basket was not fully opening up.When the device was removed from the patient, the catheter had come detached and started to slide up over the basket, not allowing the basket to fully open.The patient was not injured.A new catheter was opened to finish the procedure.
 
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Brand Name
ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
Type of Device
CATHETER EMBOLECTOMY
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11973163
MDR Text Key255410345
Report Number9680794-2021-00283
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00801902013156
UDI-Public00801902013156
Combination Product (y/n)N
PMA/PMN Number
K011056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/31/2022
Device Model NumberIPN035902
Device Catalogue NumberPT-65509
Device Lot Number13F20M0181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Initial Date Manufacturer Received 05/25/2021
Initial Date FDA Received06/10/2021
Supplement Dates Manufacturer Received07/12/2021
Supplement Dates FDA Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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