MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2021

Event Type  Injury  

Manufacturer Narrative

Event site postal code: (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the patient complained of abdominal pain.It was confirmed that the patient had a tendency to bradycardia and his blood pressure had decreased.It was noted that at this time, the console was frequently generating an augmentation alarm.It was then noticed that there was blood drawn into the tubing.The iab was immediately removed and therapy was concluded.The patient's abdominal pain was resolved after removal and reported to have been in stable condition.

Manufacturer Narrative

Correction to previous initial mdr - from health effect ¿ impact codes 2199 to 4614.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the returned non-maquet sheath.The sheath was covering the proximal taper end of the membrane.The extender tubing and pressure tubing were also returned.A catheter tubing/inner lumen kink was observed near the y-fitting at approximately 73.7cm from the iab tip.Additionally, an optical fiber break was also overserved at approximately 2.3cm from the rear seal.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, extender tubing and pressure tubing was performed and a leak was detected on the membrane at approximately 2.3cm from the rear seal and measuring approximately 0.020cm in length.The reported problems were most likely triggered by the leak found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark caused by a calcified plaque in the aorta.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 13227897
• MDR Text Key: 283620220
• Report Number: 2248146-2022-00027
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000128507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE.
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 40 KG