MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number CP-07711

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Thrombosis (2100); Diminished Pulse Pressure (2606)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed since a correct lot number was not provided by the customer and a potential lot could not be determined from a review of sales history for this customer.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

According to the medwatch (mfr report# 3012279212-2019-00003): "(b)(6)-year-old female auto vs.Pedestrian trauma presented in the evening.Patient was hemodynamically unstable on presentation.X-ray revealed vertical shear pelvic fracture.The user facility did not report which introducer sheath was used or whether the prytime er-reboa convenience kit was used.Therefore, it is unknown which introducer sheath was used.However, the user facility stocks the prytime er-reboa convenience kit thus it is possible that this kit, with the included arrow medical super arrow flex 7 fr introducer sheath, was used to gain femoral access.Access was gained int he right common femoral artery and the er-reboa catheter was placed with no issues.The catheter was 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 CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 9395463
• MDR Text Key: 168627613
• Report Number: 9680794-2019-00472
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CP-07711
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• 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: Initial
• Patient Sequence Number: 1
• Treatment: PRYTIME ER-REBOA CONVENIENCE KIT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 YR