MAUDE Adverse Event Report: GREATBATCH MEDICAL COAXIAL DILATOR ASSEMBLY, 5FR; INTRODUCER, CATHETER

Model Number 10489-003

Device Problem Break (1069)

Patient Problems Injury (2348); No Information (3190)

Event Date 01/30/2020

Event Type  Injury  

Event Description

The food and drug administration reported that a risk manager, from memorial regional hospital, submitted a sus voluntary event report for our 5f standard micro-introducer kit.The report states that a piece of the micro-introducer broke during an interventional radiology procedure.It was reported by the end user that the patient experienced a serious injury.

• Brand Name: COAXIAL DILATOR ASSEMBLY, 5FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis, mn
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, mn ; 9518115
• MDR Report Key: 10126044
• MDR Text Key: 194805109
• Report Number: 2183787-2020-00051
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D230851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10489-003
• Device Lot Number: GB5152183
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other