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 Restricted Flow rate (1248); Difficult to Flush (1251); Obstruction of Flow (2423)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name: (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 the inner lumen of the intra-aortic balloon (iab) was clotted off.The iab was removed and replaced with a new one.There was no patient harm or adverse event reported.

Manufacturer Narrative

Additional information: initial reporter: (b)(6).Email: (b)(6).Section a added patient info.Section b added other relevant history.Section h added medical - device problem code.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.Reference complaint #: (b)(4).H3 other text : device not returned.

Event Description

The following was reported via medwatch report #: (b)(4): it was reported that the intra-aortic balloon (iab) was being placed pre-operatively to act as ventricular assist post bypass.The iab was prepared normally and the central lumen was flushed pre-insertion.The iab was placed after dilation through the provided sheath.Upon insertion, the iab would not flush upon start up.The iab was then removed and a new one was inserted.There was no patient harm or adverse event reported.

Event Description

The following was reported via medwatch report # 4400150000-2021-8013: it was reported that the intra-aortic balloon (iab) was being placed pre-operatively to act as ventricular assist post bypass.The iab was prepared normally and the central lumen was flushed pre-insertion.The iab was placed after dilation through the provided sheath.Upon insertion, the iab would not flush upon start up.The iab was then removed and a new one was inserted.There was no patient harm or adverse event reported.

Manufacturer Narrative

Correction for mfg report number 2248146-2021-00246.To include: serial #: (b)(6).Reference complaint #(b)(4).

Manufacturer Narrative

Despite request and/ or customer indicated that the device would be returned; however, the device has not been returned to the manufacturer so we are unable to complete an evaluation.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period apr-2019 through mar-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

Manufacturer Narrative

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 # (b)(4).

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the catheter tubing near the y-fitting approximately 75.9cm from the iab tip.The technician attempted to flush the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an occlusion in the inner lumen.We are unable to determine how this may have occurred.The evaluation confirmed the reported problem.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 apr-2019 through mar-2021 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
• MDR Report Key: 11699564
• MDR Text Key: 246505304
• Report Number: 2248146-2021-00246
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000132558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 77