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); Difficult to Remove (1528); Pressure Problem (3012)

Patient Problem Hematoma (1884)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted complaint record id # (b)(4).

Event Description

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.Extracorporal tubing filled with blood.The therapy was 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 investigation.

Manufacturer Narrative

Updated/ additional information - patient info, lot #, manufacture date,exp.Date, evaluation method codes.Additional initial reporter name, occupation, email,telephone - (b)(6), nurse, (b)(6), (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id #: (b)(4).H3 other text : device not returned.

Event Description

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.Extracorpeal tubing filled with blood.The therapy was 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 endarderectomy 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 investigation.Mw5097803 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 and did not deflate completely causing a tear in the femoral artery.The artery was patched successfully without complication.Plaque was noted in the artery.

• 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 07004
• MDR Report Key: 10878278
• MDR Text Key: 217680398
• Report Number: 2248146-2020-00623
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000121471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE.
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 77