MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

Device Problems Material Frayed (1262); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as, "at the time of removing the metal guide from the catheter, the doctor says that it becomes difficult, having to advance the catheter more than allowed to be able to remove the guide that at that time was bent, when the guide comes out the doctor finds it in his distal part open and frayed, causing lacerations in the intima of the vessel. " no patient complication was reported. The patient's condition was reported as critical unrelated to the device issue.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 10824061
• MDR Text Key: 216009159
• Report Number: 3006425876-2020-00945
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F20F2150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial