MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Device Alarm System (1012); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/07/2018

Event Type  Death  

Manufacturer Narrative

Additional information: contact at event site reported to distributor, (b)(6).Complete facility name reported as: (b)(6).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.(b)(4).

Event Description

The patient presented with acute cardiogenic shock and was admitted to the hospital.After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low.After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal.It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm.Therapy was terminated.There was reported difficulty removing the iab catheter from the patient and surgical removal was required.

Manufacturer Narrative

Correction: outcomes of adverse event: selected 'death' and added date of death (b)(6) 2018.Describe event or problem added statement 'the patient expired on (b)(6) 2018, but the death was not attributed to the device'.Type of reportable event: selected death.(b)(4).

Event Description

The patient presented with acute cardiogenic shock and was admitted to the hospital.After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low.After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal.It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm.Therapy was terminated.There was reported difficulty removing the iab catheter from the patient and surgical removal was required.The patient expired on (b)(6) 2018, but the death was not attributed to the device.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 20.6cm from iab tip and the tip of the inner lumen was out of place inside the membrane.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and another leak was detected on the membrane approximately 4.3cm from the rear seal measuring 4.1cm in length.The evaluation confirms the reported leak, blood in tubing & difficult/unable to remove iab from patient problems.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported blood in tubing and difficult/unable to remove iab from patient problems.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.

Event Description

The patient presented with acute cardiogenic shock and was admitted to the hospital.After emergency percutaneous coronary intervention (pci), their hemodynamic state was unstable and their blood pressure was low.After initiation of intra-aortic (iab) balloon therapy, the patient was reported to be normal.It was reported that after approximately two days of iab therapy, there was blood found in the iab catheter tubing, but the pump did not alarm.Therapy was terminated.There was reported difficulty removing the iab catheter from the patient and surgical removal was required.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7313509
• MDR Text Key: 101507274
• Report Number: 2248146-2018-00142
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000055094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 03/13/2018; 03/06/2018
• Supplement Dates FDA Received: 04/06/2018; 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 46