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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
No additional information is available for this event as the article does not provide any contact information on the author. In addition, the article did not provide information on the manufacturer of the iabp, pump model or serial number.
 
Event Description
The following was reported via an article reviewed by getinge:an (b)(6) female with a past medical history significant for coronary artery disease (cad) presented with sudden onset of typical chest pain. Her vital signs were significant for a blood pressure of 85/45 mmhg, heart rate of 93 beats per minute (bpm), respiratory rate of 18 and an oxygen saturation of 99% on room air. She was in mild distress, with normal heart and lung sounds. Her troponin was found to be elevated to 0. 036 ng/ml (normal level <0. 031), then 0. 016 ng/ml seven hours later along with resolution of admission symptoms. Ecg revealed a normal sinus rhythm at a rate of 88 bpm. A prior coronary angiogram revealed a 90¿95% occlusion of the right coronary artery (rca) 2 months prior that was medically managed due to technically difficult, severely calcified and tortuous vessel. The patient was initially treated as a non-stemi and planned for rotational atherectomy followed by percutaneous transluminal angioplasty (pci) using trans-radial approach. For all cases, consent was obtained from all patients. During first pass of the rotablator¿ rotational atherectomy system (boston scientific corporation, ma, usa), she developed transient slow flow and subsequent hemodynamic instability and thirddegree atrioventricular heart block, requiring temporary transvenous pacing and iabp placement. In all subsequent cases, appropriate precautions for balloon pump insertion were successfully performed. We used a sheathed insertion technique with an 8 french sheath for insertion of the iabp. Appropriate function and positioning of the iabp was confirmed with fluoroscopy. Revascularization of the rca with placement of a drug eluting stent was successfully performed. The patient required a short stay in the coronary care unit (ccu) with dopamine infusion support. Removal of the iabp at bedside in the ccu with careful technique and care was complicated by entrapment and resistance (figure 1) likely due to severe calcification. Under fluoroscopy guidance, the iabp was removed and this was complicated by a left femoral artery tear and perforation (figure 2). Hemostasis of the groin access site was achieved with manual pressure. The patient required five units of packed red blood cells, one unit of platelets and fresh frozen plasma over the next 24 h and remained hemodynamically stable. On day 2, imaging revealed a 1. 3 × 1. 6 cm pseudoaneurysm. Interventional radiology was consulted; successful thrombin injection was performed for treatment of the pseudoaneurysm. The patient continued to improve without further signs of bleeding or ischemia and was discharged 1 week later. Related balloon complaint # for case #1 tw# (b)(4).
 
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Brand NameUNKNOWN IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10453732
MDR Text Key204873601
Report Number2249723-2020-01344
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/26/2020 Patient Sequence Number: 1
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