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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problem Material Rupture (1546)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Ischemia (1942); Nausea (1970); Occlusion (1984); Vomiting (2144); Numbness (2415)
Event Date 12/28/2017
Event Type  Death  
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 2. 5cm from the rear seal measuring 0. 025cm in length. The reported blood in tubing and alarm were most likely triggered by a leak which was found on the membrane. Under magnification, a whitish patch was observed around the leak. This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta. The evaluation confirmed the reported problem. An abrasion leak is a known inherent risk and common failure mode caused by calcified plaque in the aorta. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was reported that a patient had an intra-aortic balloon (iab) ruptured during procedure. The patient was transferred to the facility as a high risk percutaneous coronary intervention (pci) patient and had a competitor device inserted in left groin from a different facility. The patient required a right coronary artery (rca) spiral dissection and competitor device removal. After removal of competitor iab, a 34cc linear was inserted in the left groin at customer site on (b)(6) 2017 at 17:00. Sometime after insertion there was an alarm generated which created a concern that there may have been an iab rupture. Upon arrival at bedside it was noted that the patient had blood in the iab pressure tubing and iab pump console had been on standby for about 5 minutes with alarms indicating rupture. At that time the patient was on vasopressin 0. 02 units/min as well as dobutamine (dba) at 5 mcg/kg/min. Patient's blood pressure started to drop without iab assistance, norepinephrine was initiated to maintain mean arterial pressure (map) above 65 mmhg. Norepinephrine at 0. 7 mcg/kg/min in addition to the vasopressin at 0. 04 units/min was required to maintain her map goal during this time. Patient also became nauseated and had episodes of vomiting during this time with increasing pressor requirements. On (b)(6) 2017 at 22:30 it was noted that there was an iab rupture. Decision was made to urgently replace the iab via patient¿s right common femoral artery (cfa) at bedside. After speaking with the physician the iab was removed from the left cfa 8fr sheath and then proceeded to remove the sheath. No thrombus was seen at the time of bleed back once the sheath was removed iab was intact and was saved to be checked by the manufacturer. Hemostasis of her left cfa access site was achieved with manual pressure. Patient¿s groin was prepped and all five maximum sterile barriers were used. Patient was given local anesthetic with lidocaine 1% without epinephrine at the right cfa site. A micro-puncture catheter was used to obtain right cfa access and a 4fr sheath was initially placed in the right cfa. Appropriate placement was confirmed via chest x-ray (cxr); iab was secured with suture and stat locks and a clear dressing was applied. The second iab (mega 40cc) was inserted successfully. Post-procedure, patient had good augmentation with blood pressure (b/p) to the 150's. Pressors were weaned off and patient remained only on dba at 5 mcg/kg/min. Patient did not have left dorsalis pedis (dp), posterior tibial (pt), or popliteal pulses by doppler. Right pt was present as a monophasic waveform with doppler, however right dp was not present with doppler. Patient was started on heparin gtt (drops) without bolus about 1 hour after iabp placement urgently a complete blood count (cbc) was checked. 1gm intravenous (iv) vancomycin also was given for prophylaxis. Bear hugger and warming blanket applied to patient's legs. At 06:20 patient had b/l dp and pt pulses present with doppler. Testing was performed for hemoglobin (hgb), creatinine (cr), mixed venous oxygen saturation (svo2), central venous pressure (cvp), and urinary output (uop). Furosemide gtt was at 20 mg/hr, also decided to add iv chlorothiazide 250 mg x 1 and monitor uop. Approximately 8 hours later on (b)(6) 2017 at 07:00 patient complained about tingling/numbness to left foot. Patient could not feel anything from knee down to foot. An ultrasound showed nearly occluded left cfa & possibly nearly occluded external iliac artery (eia). Lowered flow velocities were noted throughout entire left lower leg. Limb ischemia reported prior to patient death. Patient death occurred on (b)(6) 2018. Indication for use: multivessel disease. This is report 1 of 2 for iab (linear 34cc).
 
Manufacturer Narrative
Concomitant medical products: vasopressors (vaso) 0. 04 units/min, epinephrine (ep) 0. 04 units/hr, dubutamine 5 mcg, metformin 500 mg, aspirin (asa) 81 mg. 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. (b)(4).
 
Event Description
It was reported that a patient had an intra-aortic balloon (iab) ruptured during procedure. The patient was transferred to the facility as a high risk percutaneous coronary intervention (pci) patient and had a competitor device inserted in left groin from a different facility. The patient required a right coronary artery (rca) spiral dissection and competitor device removal. After removal of competitor iab, a 34 cc linear was inserted in the left groin at customer site on (b)(6) 2017 at 17:00. Sometime after insertion there was an alarm generated which created a concern that there may have been an iab rupture. Upon arrival at bedside it was noted that the patient had blood in the iab pressure tubing and iab pump console had been on standby for about 5 minutes with alarms indicating rupture. At that time the patient was on vasopressin 0. 02 units/min as well as dobutamine (dba) at 5 mcg/kg/min. Patient's blood pressure started to drop without iab assistance, norepinephrine was initiated to maintain mean arterial pressure (map) above 65 mmhg. Norepinephrine at 0. 7 mcg/kg/min in addition to the vasopressin at 0. 04 units/min was required to maintain her map goal during this time. Patient also became nauseated and had episodes of vomiting during this time with increasing pressor requirements. On (b)(6) 2017 at 22:30 it was noted that there was an iab rupture. Decision was made to urgently replace the iab via patient¿s right common femoral artery (cfa) at bedside. After speaking with the physician the iab was removed from the left cfa 8fr sheath and then proceeded to remove the sheath. No thrombus was seen at the time of bleed back once the sheath was removed iab was intact and was saved to be checked by the manufacturer. Hemostasis of her left cfa access site was achieved with manual pressure. Patient¿s groin was prepped and all five maximum sterile barriers were used. Patient was given local anesthetic with lidocaine 1% without epinephrine at the right cfa site. A micro-puncture catheter was used to obtain right cfa access and a 4fr sheath was initially placed in the right cfa. Appropriate placement was confirmed via chest x-ray (cxr); iab was secured with suture and stat locks and a clear dressing was applied. The second iab (mega 40 cc) was inserted successfully. Post-procedure, patient had good augmentation with blood pressure (b/p) to the 150's. Pressors were weaned off and patient remained only on dba at 5 mcg/kg/min. Patient did not have left dorsalis pedis (dp), posterior tibial (pt), or popliteal pulses by doppler. Right pt was present as a monophasic waveform with doppler, however right dp was not present with doppler. Patient was started on heparin gtt (drops) without bolus about 1 hour after iabp placement urgently a complete blood count (cbc) was checked. 1 gm intravenous (iv) vancomycin also was given for prophylaxis. Bear hugger and warming blanket applied to patient's legs. At 06:20 patient had b/l dp and pt pulses present with doppler. Testing was performed for hemoglobin (hgb), creatinine (cr), mixed venous oxygen saturation (svo2), central venous pressure (cvp), and urinary output (uop). Furosemide gtt was at 20 mg/hr, also decided to add iv chlorothiazide 250 mg x 1 and monitor uop. Approximately 8 hours later on (b)(6) 2017 at 07:00 patient complained about tingling/numbness to left foot. Patient could not feel anything from knee down to foot. An ultrasound showed nearly occluded left cfa & possibly nearly occluded external iliac artery (eia). Lowered flow velocities were noted throughout entire left lower leg. Limb ischemia reported prior to patient death. Patient death occurred on (b)(6) 2018. Indication for use: multivessel disease. This is report 1 of 2 for iab (linear 34 cc).
 
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Brand NameLINEAR 7.5 FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7223825
MDR Text Key106049720
Report Number2248146-2018-00051
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number0684-00-0474
Device Lot Number3000060742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2018 Patient Sequence Number: 1
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