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

Catalog Number PT-65709-W

Device Problem Break (1069)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports the ptd basket broke.

Manufacturer Narrative

Qn#(b)(4).Additional information was received indicating the issue occurred during use.It was also reported that there was no harm to the patient and the patient is in stable condition.There was no intervention required other than removal of the device and opening a new ptd basket.Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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 ptd basket broke.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10436721
• MDR Text Key: 203838075
• Report Number: 9680794-2020-00335
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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: No Information
• Device Catalogue Number: PT-65709-W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1