MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number IPN036455

Device Problem Material Integrity Problem (2978)

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

Event Date 06/14/2019

Event Type  malfunction  

Event Description

Tip of catheter is getting stripped.Potential for vascular damage.8.5 french, 20 cm., 0.032 inch diameter spring wire guide.

• Brand Name: ARROW
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8944487
• MDR Text Key: 155962677
• Report Number: 8944487
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30801902117275
• UDI-Public: (01)30801902117275
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN036455
• Device Catalogue Number: CDC-45854-P1A
• Device Lot Number: 13F19C0497
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Date Report to Manufacturer: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1