MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

Complete reporter name: (b)(6) occupation - msn, rn, ccrn-cmc.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 record id (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) displayed low alarm for battery use and the helium line had what appeared to be blood in it.The nurse staffs and the interventional cardiologist reported issues with either the iab or the iabp that required urgent removal at the bedside.The patient had the iab inserted on (b)(6) 2024 in the cath lab for severe 3v cad.The rn went into the patient's room at (b)(6) because they were getting the low alarm for battery use.Another rn was in the room and noted that the helium line had what appeared to be blood in it.The rn immediately reported to the provider and interventional attending md.The iab was successfully removed.The clinical team decided not to insert a new iab.The interventional cardiologist came to evaluate the iab and noted that there was no rupture.The interventional cardiologist believed that it was a console failure and wanted it investigated further.They also examined the iab by inflating it.When this was done, what was seen (on video) was black color materials (pebbles) circulating within the iab portion during inflation.The helium tubing portion has small amount of light blood tinged color fluid with sediments.There was no patient harm or adverse event reported.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number.

Manufacturer Narrative

The iab 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 not a maquet product.The extender tubing was also returned.The extracorporeal tubing was returned cut in two parts.A kink was observed on the catheter tubing and inner lumen approximately 75.7cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and a leak was observed on the catheter tubing a the kinked location of 75.7cm.The penetration found in the catheter tubing appears to have been caused by a kink flexing back and forth that eventually penetrated the tubing causing the reported problem.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).

Event Description

N/a.

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) displayed low alarm for battery use and the helium line had what appeared to be blood in it.The nurse staffs and the interventional cardiologist reported issues with either the iab or the iabp that required urgent removal at the bedside.The patient had the iab inserted on (b)(6) 2024 in the cath lab for severe 3v cad.The rn went into the patient's room at 2027 because they were getting the low alarm for battery use.Another rn was in the room and noted that the helium line had what appeared to be blood in it.The rn immediately reported to the provider and interventional attending md.The iab was successfully removed.The clinical team decided not to insert a new iab.The interventional cardiologist came to evaluate the iab and noted that there was no rupture.The interventional cardiologist believed that it was a console failure and wanted it investigated further.They also examined the iab by inflating it.When this was done, what was seen (on video) was black color materials (pebbles) circulating within the iab portion during inflation.The helium tubing portion has small amount of light blood tinged color fluid with sediments.There was no patient harm or adverse event reported.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number 2249723-2024-00849.The following was reported via medwatch report # (b)(4) received on 06may2024: iabp only alarming low battery, when plugging into red outlet - noted that there was discoloration in the helium line.Cicu fellow, house staff, and cicu app made aware.Cicu attending and interventional fellow also called.Iabp was removed successfully and examined by dr and interventional fellow.Iabp console and catheter set aside for further investigation.Debris noted.Patient monitored and requires no further intervention at this time.Of note the console did not give a stat alarm.Maquet iabp s/n (b)(6).

Manufacturer Narrative

Medwatch report # (b)(4) received 06may2024 - updated field(s): describe event or problem.Other relevant history.Initial report sent to fda? report source / other source - please specify.Additional reporter: (b)(6).

• Brand Name: SENSATION PLUS 7.5FR. 40CC 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: 18855410
• MDR Text Key: 337095422
• Report Number: 2248146-2024-00149
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000319341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/19/2024; 05/06/2024
• Supplement Dates FDA Received: 03/19/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE (B)(6)
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 61 KG