MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

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

It was reported that during intra-aortic balloon (iab) therapy the customer had seen blood inside the helium tubing.The patient was stable.The customer was advised to disconnect the iab from the console and remove the iab from the patient.Upon follow up approximately 40 minutes later.The iab still had not been removed.The console was in standby.The customer was advised to disconnect the helium tubing and power down the console.The customer was advised again that the iab needed to be removed as soon as possible.There was no patient harm or adverse event reported.

Manufacturer Narrative

Additional/updated information: medwatch received, adverse event/product problem, outcome attributed to ae, describe event or problem, report source,other source - please specify,type of reportable event, medical device ¿ problem code,health effect ¿ clinical code, health effect ¿ impact codes.Additional initial reporter information: (b)(6) / nurse / (b)(6).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

It was reported that during intra-aortic balloon (iab) therapy the customer had seen blood inside the helium tubing.The patient was stable.The customer was advised to disconnect the iab from the console and remove the iab from the patient.Upon follow up approximately 40 minutes later.The iab still had not been removed.The console was in standby.The customer was advised to disconnect the helium tubing and power down the console.The customer was advised again that the iab needed to be removed as soon as possible.There was no patient harm or adverse event reported.It was later reported via medwatch mw5100928.On (b)(6) 2021 at 1600, alarm condition "restriction" noted by bedside nurse, blood noted in the helium line by bedside rn, iabp function ceased, (b)(6) notified of alarm and condition.Maquet contacted for troubleshooting, (b)(6) contacted.Patient transported to the cath lab for iab catheter removal.Cardiac surgeon was asked to assist removing required cutdown and removal with "significant resistance".Noted on removal significant debris inside the balloon pump itself; sent to pathology for evaluation.Pathology report reports material in the devise was desiccated thrombus; repeated alarms day of removal for loos of gas; blood in tubing; the specimen is labeled with the patient's name and date of birth.The specimen consists of a 124.3cm in length by 0.9cm in greatest diameter medical device with plastic and metallic segments.Photographs are taken.There is a bag like segment at one end that measures 26.5 x 2.6 x 0.2cm.There are is dried blood within the segment.At the end of this segment, there is a 0.6cm in greatest dimension plastic tip.Adjacent to the segment, is a 12cm in length metallic segment with a clasp.Protruding off the clasp, there is a 20.9cm in length by 0.3cm in greatest diameter clear tube with blood within the tube with a clasp with yellow closures at the end.There is a 2nd segment of plastic bag surrounding a metallic segment.Adjacent to this segment, there is a hard white plastic segment with a medical id that reads maquet sensation plus 8fr 500cc.Protruding office white plastic segment, there is a cylindrical segment with a medical id that reads (b)(6).There is an additional protrusion off the white segment that has a 1.9cm in length metallic segment and a 7.6cm in length orange segment with a green yellowish fiber material protruding from the end.There is no tissue grossly identified.The specimen is for gross examination only.Fda safety report id# (b)(4).

Event Description

N/a.

Manufacturer Narrative

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 not a maquet product.The senor cable and connector was cut from the iab and not returned.A kink was found on the inner lumen and catheter tubing near the y-fitting approximately 76.5cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and five leaks were detected on the membrane approximately (3) 18.3cm and (2) 18.8cm from the rear seal measuring (2) 0.089cm and (3) 0.203cm in length.The reported problems was most likely triggered by the leak found on the membrane.The penetrations found on the membrane appear to have been caused by a sharp object.We are unable to determine when this may have occurred.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period may-19 to apr-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 11768947
• MDR Text Key: 248880315
• Report Number: 2248146-2021-00283
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

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: 10/12/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000134412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 05/06/2021; 12/01/2021
• Supplement Dates FDA Received: 05/30/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 79 KG