MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CA-25703-A

Device Problem Entrapment of Device (1212)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the guide wire was left in the patient inside of the catheter.There was an intervention as the patient was sent to another department so the device could be removed by being snared.The complete device was removed under ct without incident.The patient condition is reported as ok.

Manufacturer Narrative

Qn#(b)(4).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 guide wire was left in the patient inside of the catheter.There was an intervention as the patient was sent to another department so the device could be removed by being snared.The complete device was removed under ct without incident.The patient condition is reported as ok.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9279074
• MDR Text Key: 177799070
• Report Number: 9680794-2019-00430
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CA-25703-A
• Device Lot Number: 13F19F0543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention