MAUDE Adverse Event Report: TELEFLEX ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH INTRODUCER, CATHETER

Model Number CP-07711

Device Problem Use of Device Problem (1670)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

(b)(6) female auto vs. Pedestrian trauma presented in the evening. Patient was hemodynamically unstable on presentation. X-ray revealed vertical shear pelvic fracture. Er-reboa catheter was placed in the right common femoral artery with no issues, and only "briefly" deployed. Upon removal of the introducer sheath the following morning, the patient displayed diminished pulses in the right lower extremity. There were concerns about a right common femoral/external iliac artery dissection and clot after viewing the ct. A thrombectomy was performed during which the artery was found to be normal.

• Brand Name: ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX
• Manufacturer (Section G): PRYTIME MEDICAL DEVICES, INC.; 229 north main street; boerne TX 78006
• Manufacturer Contact: brian young ; 229 north main street; boerne, TX 78006 ; 2103400116
• MDR Report Key: 9276243
• MDR Text Key: 166115810
• Report Number: 3012279212-2019-00003
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CP-07711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/04/2019 Patient Sequence Number: 1