MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED

Model Number IPN000099

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that an swg (0.025inch) did not go through the catheter.As a result, the user opened a new kit, and the swg successfully went through the new catheter and the procedure was completed without problem.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the "swg did not go through the catheter " is confirmed.Upon return, the injection lumen failed aspiration and flush testing due to a blood clot.The blood clot was cleared from the injection lumen after the guidewire test and another attempt of aspirating and flushing was successfully completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that an swg (0.025inch) did not go through the catheter.As a result, the user opened a new kit, and the swg successfully went through the new catheter and the procedure was completed without problem.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: THERMISTOR 7 110CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10860948
• MDR Text Key: 216893947
• Report Number: 3010532612-2020-00355
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902004567
• UDI-Public: 00801902004567
• Combination Product (y/n): N
• PMA/PMN Number: K823433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IPN000099
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F20F0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1