MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR TERUMO CARDIOVASCULAR; RIGID INTRACARDIAC SUCKER

Model Number 4300S

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

It was reported by the customer a pouch was unsealed at the bottom.This was identified prior to use.No injury/death was reported.

• Brand Name: TERUMO CARDIOVASCULAR
• Type of Device: RIGID INTRACARDIAC SUCKER
• Manufacturer (Section D): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer (Section G): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial drive ne; grand rapids, MI 49505 ; 6168211323
• MDR Report Key: 17013730
• MDR Text Key: 316200709
• Report Number: 3017540705-2023-00001
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00817278011399
• UDI-Public: 00817278011399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971022
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

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: 4300S
• Device Catalogue Number: 4300S
• Device Lot Number: 06217-113022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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