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

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

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).

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).

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, 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 Key: 7223825
• MDR Text Key: 98858106
• Report Number: 2248146-2018-00051
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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 Received: 01/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000060742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 50