MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Hematoma (1884)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and noted that blood had completely overwhelmed the pneumatic module assembly including the safety disk.Blood continued to intrude into the iabp unit and gathered mostly on the power management board.In addition, the stm observed that the fiber optic module had excessive corrosion throughout caused by saline intrusion.Repairs are pending customer approval.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use, the balloon of the cardiosave intra-aortic balloon pump (iabp) unit burst resulting in a blood back issue.The patient in cardiovascular intensive care unit (cvicu) with intra-aortic balloon catheter inserted in right groin.Patient very restless, and not keeping lower extremities still.Upon repositioning patient for comfort, augmentation decreased then patient no longer augmenting and augmentation alarm was going off.Extra-corpeal tubing filled with blood.Therapy stopped.New iab catheter placed in left groin.Upon trying to remove catheter from right groin, increased resistance met and patient complaining of discomfort.Patient went to surgery for open visual endarterectomy to have catheter removed surgically.Small hematoma then noted on right groin after surgical removal.No further problem noted.Patient to cardiac bypass surgery on (b)(6) 2020, as originally scheduled.Balloon was discarded after removal and not available for return.Patient needed to have iab catheter surgically removed due to increased resistance met when trying to remove through sheath after blood noted in tubing.It is unknown if the patient¿s injury is attributed to the iabp.

Event Description

Additional information received via medwatch: while pt was in the cvicu the pt turned in bed and blood was noted in the iabp (which was placed on (b)(6) 2020).The gath lab team was called in to remove the iabp under fluoroscopy.The interventional cardiologist was unable to remove the iabp end called vascular surgery.Vascular surgery took the patient to the or end did a cut down to remove the balloon.It was noted that the balloon was ruptured und did not deflate completely causing a tear in the femoral artery.The artery was patched successfully without complication.Plaque was noted in the artery.

Event Description

While pt was in the cvicu the pt turned in bed and blood was noted in the iabp (which was placed on (b)(6) 2020).The cath lab team was called in to remove the iabp under fluoroscopy.The interventional cardiologist was unable to remove the iabp end called vascular surgery.Vascular surgery took the patient to the or end did a cut down to remove the balloon.It was noted that the balloon was ruptured und did not deflate completely causing a tear in the femoral artery.The artery was patched successfully without complication.Plaque was noted in the artery.

Manufacturer Narrative

A getinge field service engineer (fse) replaced the pneumatic module assembly and the power management board.Although the fiber-optic circuit board showed visible signs of corrosion, at the customer¿s request, this was not addressed.The fse performed full calibration and functional check and unit passed all tests to meet factory specifications.The unit was returned to the customer and cleared for clinical use.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported 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.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 12 month product complaint trend data for the period ((b)(6) 2019 through (b)(6)2020) was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10906071
• MDR Text Key: 219569792
• Report Number: 2249723-2020-02023
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• 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
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC.
• Patient Outcome(s): Other