MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET; CATHETER EMBOLECTOMY

Catalog Number PT-65509

Device Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot# unknown.Potential lot# 13f18l0852.Complaint verification testing could not be performed because a sample was not returned for analysis.A device history record review was performed based on sales history and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.The ifu provided with this kit describes suggested techniques to minimize the likelihood of ptd catheter damage during use.It states that if the flexible tip "folds over" itself when it encounters the sheath valve, insert the folded-over tip through the valve and pull back slightly to allow the tip to unfold in the open cavity of the hub.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: it contains the caution to keep the exposed portion of the ptd catheter straight at all times to aid in successful basket deployment and the warning not to advance the ptd catheter forward during activation.A corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without sample.

Event Description

The customer reports a tip separation of the device.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
• Type of Device: CATHETER EMBOLECTOMY
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 8703628
• MDR Text Key: 148169643
• Report Number: 9680794-2019-00226
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

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 Catalogue Number: PT-65509
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1