MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that in an emergency surgery, the intra-aortic balloon (iab) was difficult to advance through maquet sheath.The iab was replaced to continue therapy.There was no patient injury reported.

Event Description

It was reported that in an emergency surgery, the intra-aortic balloon (iab) was difficult to advance through maquet sheath.The iab was replaced to continue therapy.There was no patient injury reported.

Manufacturer Narrative

The product was returned with the membrane loosely folded and blood on the exterior of the catheter.The sheath was not returned for evaluation.A kink was found in the catheter tubing approximately 49.3cm from the iab tip.- a laboratory insertion test was unable to be performed due to the membrane being unfurled.- the technician then attempted to insert a laboratory 0.018¿ guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.- an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that in an emergency surgery, the intra-aortic balloon (iab) was difficult to advance through maquet sheath.The iab was replaced to continue therapy.There was no patient injury reported.

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint #(b)(4); record id (b)(4).

• Brand Name: TRANS-RAY 7FR. 34CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8185799
• MDR Text Key: 131341024
• Report Number: 2248146-2018-00743
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2018
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000021401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Device Age: YR
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1