MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number CP-07711

Device Problem Use of Device Problem (1670)

Patient Problems Intimal Dissection (1333); Thrombosis (2100)

Event Date 06/11/2019

Event Type  Injury  

Event Description

(b)(6) hospital, placenta percreta patient.(b)(6) year old, female, (b)(6).Prytime er-reboa convenience kit was utilized to gain access to deploy an er-reboa catheter for control of hemorrhage.Ultrasound used for placement of femoral arterial line.No resistance with insertion of catheter to zone 3.Physician inflated to 6 ml for 33 minutes, took down for a period of time and then inflated again with 3 ml for partial occlusion for 14 minutes.Balloon was confirmed by palpation transabdominal.No resistance at catheter removal.Patient started to bleed again after removal of catheter due to aberrant placental vessels invading the bladder.Second catheter was placed in zone 3, no resistance, inflated with 5 ml for 29 minutes.Bleeding was controlled and 2nd catheter was removed but femoral access was maintained.While moving the patient, the introducer sheath became dislodged and came approximately halfway out of the patient.The sheath was pushed back in blindly by ob fellow.It was identified through physical examination and ultrasound that the cfa had thrombosed with a dissection to the external iliac artery.Patient was taken to or with ir and vascular surgery for angiogram and repair.Patient ultimately discharged with no limb loss.100 units of blood used during this case and according to dr.Marc de moya, he feels the patient would have died without the use of the catheter and regrets not placing the sheath prophylactically.

• Brand Name: ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville rd; reading PA 19605
• Manufacturer (Section G): PRYTIME MEDICAL DEVICES, INC; 229 n main street; boerne TX 78006
• Manufacturer Contact: brian young ; 229 n main street; boerne, TX 78006 ; 2103400116
• MDR Report Key: 8809778
• MDR Text Key: 151705798
• Report Number: 3012279212-2019-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CP-07711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 75