MAUDE Adverse Event Report: DATASCOPE CORP. 8 F 50 CC SENSATION PLUS IABP CATHETER (MAQUET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-1576-01U

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/13/2021

Event Type  Injury  

Event Description

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 device 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 124.3 cm in length by 0.9 cm 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 0.2 cm.There are is dried blood within the segment.At the end of this segment, there is a 0.6 cm in greatest dimension plastic tip.Adjacent to the segment, is a 12 cm in length metallic segment with a clasp.Protruding off the clasp, there is a 20.9 cm in length by 0.3 cm 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 a 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 8 fr.500 cc.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 1.9 cm in length metallic segment and a 7.6 cm 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).

• Brand Name: 8 F 50 CC SENSATION PLUS IABP CATHETER (MAQUET)
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ 07004
• MDR Report Key: 11706135
• MDR Text Key: 247036879
• Report Number: MW5100928
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2021

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 Model Number: 0684-00-1576-01U
• Device Catalogue Number: 0684-00-1576-01U
• Device Lot Number: 30000141028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 112