MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 5; CATHETER, EMBOLECTOMY

Catalog Number PT-45509

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Mdr report key: 10424962.Mdr text key: 203478652.Report# mw5096058.

Event Description

According to the maude report: "during thrombectomy procedure, the tip of the ptd device broke off inside the patient.The device is a teleflex arrow ptd.Reference number (b)(4), lot # 13f20d0402.Device retracted immediately and not used again.2 stents placed in tandem to cover stenotic vein and area of sheared off tip of thrombectomy device".

Event Description

According to the maude report: "during thrombectomy procedure, the tip of the ptd device broke off inside the patient.The device is a teleflex arrow ptd.Reference number (b)(4), lot # 13f20d0402.Device retracted immediately and not used again.2 stents placed in tandem to cover stenotic vein and area of sheared off tip of thrombectomy device".

Manufacturer Narrative

(b)(4).Mdr report key 10424962/mdr text key 203478652/report# mw5096058 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.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 5
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10659952
• MDR Text Key: 212769906
• Report Number: 9680794-2020-00403
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: PT-45509
• Device Lot Number: 13F20D0402
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/10/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention