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

Catalog Number PT-65509

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the doctor made 3 passes with the first catheter, and pulled the catheter out to be cleaned by the tech.When the tech wiped off the catheter and inspected it prior to giving it back to the physician, he noticed the tip was missing.The tip was located under fluoro and snared out of the vessel.The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was reported to be delayed/interrupted.

Manufacturer Narrative

Qn#(b)(4).Medwatch# mw5091655.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed 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.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports: the doctor made 3 passes with the first catheter, and pulled the catheter out to be cleaned by the tech.When the tech wiped off the catheter and inspected it prior to giving it back to the physician, he noticed the tip was missing.The tip was located under fluoro and snared out of the vessel.The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was reported to be delayed/interrupted.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
• Type of Device: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9511001
• MDR Text Key: 172447752
• Report Number: 9680794-2019-00497
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F19F0437
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention