MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Failure to Advance (2524)

Patient Problems Calcium Deposits/Calcification (1758); Hypoxia (1918); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 12/08/2017

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 during intra-aortic balloon (iab) insertion, the iab would not advance or pass through the sheath.The indication for use was due to patient being admitted due to acute myocardial infarction with elevation of the st segment in the inferior wall with electrical extension to the right ventricle without success criteria for thrombolysis, for which rescue angioplasty was performed.It went from an emergency to a cardiac catheterization with evidence of severe multivessel coronary disease and extensive calcifications, with a critical lesion in the proximal third and middle of the right coronary artery with a high thrombotic load; mechanical recanalization, angioplasty and stent implantation were performed, a non-surgical approach.Due to severe reflux with intracoronary, adenosine was required.Cardiogenic shock with hypoxemia then occurred, for which orotracheal intubation was performed and required mechanical support with iab.The iab would not advance, the iab was checked and verified to be adequate, however due to the instability of the patient the iab was replaced.The replacement iab was inserted successfully and therapy started without complications.There was no reported injury to the patient.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The extender tubing was also returned.The sheath was not returned for evaluation.Two kinks were found on the catheter tubing near the y-fitting approximately 74.4cm and 76.2cm from the iab tip.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender 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.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the iab would not advance or pass through the sheath.The indication for use was due to patient being admitted due to acute myocardial infarction with elevation of the st segment in the inferior wall with electrical extension to the right ventricle without success criteria for thrombolysis, for which rescue angioplasty was performed.It went from an emergency to a cardiac catheterization with evidence of severe multivessel coronary disease and extensive calcifications, with a critical lesion in the proximal third and middle of the right coronary artery with a high thrombotic load; mechanical recanalization, angioplasty and stent implantation were performed, a non-surgical approach.Due to severe reflux with intracoronary, adenosine was required.Cardiogenic shock with hypoxemia then occurred, for which orotracheal intubation was performed and required mechanical support with iab.The iab would not advance, the iab was checked and verified to be adequate, however due to the instability of the patient the iab was replaced.The replacement iab was inserted successfully and therapy started without complications.There was no reported injury to the patient.

• Brand Name: SENSATION 7FR. 40CC 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: 7188711
• MDR Text Key: 97479695
• Report Number: 2248146-2018-00020
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063525
• 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
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000048410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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 Age: 84 YR
• Patient Weight: 90