MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TITAN STAB W/BALL ATT; UNIVERSAL STABILIZER ARM

Model Number T401231U

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).Results : results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the device had poor holding performance.No consequences or impact to patient; product was changed out; it was unknown if there was a delay; procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on jul 2, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected.There was no damage of the returned package.The sample was subjected to vacuum while being pressed against a glove to determine if there was any reduced performance.One of the holes was not operating as intended.This confirms that there is suboptimal performance on one foot of the distal end of the stabilizer.A retention sample from the same lot was taken and tested similarly, showing that proper vacuum could be achieved.Potential root causes of this defect are damage to the u tube or foot, or silicone occlusion during the welding process at the supplier.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: TITAN STAB W/BALL ATT
• Type of Device: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7656061
• MDR Text Key: 113002244
• Report Number: 1124841-2018-00129
• Device Sequence Number: 0
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T401231U
• Device Catalogue Number: N/A
• Device Lot Number: 171101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1