MAUDE Adverse Event Report: ARROW INTERNATIONAL, INCORPORATED; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 6747

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

It was reported that the physician tested the balloon catheter by inflating it prior to the implant procedure.The balloon would not deflate and physician chose to use a different product.No patient involvement.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: NA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ARROW INTERNATIONAL, INCORPORATED; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer (Section G): ARROW INTERNATIONAL, INCORPORATED; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9235970
• MDR Text Key: 165776037
• Report Number: 2124215-2019-22244
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K021283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

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: Health Professional
• Device Model Number: 6747
• Device Catalogue Number: 6747
• Device Lot Number: 16F19A0034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 10/24/2019
• 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