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.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

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
• 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
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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 Expiration Date: 03/27/2022
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F20F2150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Age: 82 YR