MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number 500-56112

Device Problems Device Alarm System (1012); Obstruction of Flow (2423); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2021

Event Type  Injury  

Event Description

It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic endovascular device was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After catheter placement, the patient was moved to the intensive care unit (icu).Shortly after arrival to the icu, the hospital supplied infusion pump alarmed with a downstream occlusion to the drug line on both infusion pumps.Stopcocks and roller clamps were reported to be open.No catheter kinks were noted.The user flushed the line with a 10c and a 3cc syringe for no resolution.The drug infusion pump was also replaced and the alarm continued.All troubleshooting steps were exhausted.The physician decided to bring the patient back to the catheterization lab for catheter replacement.No further issues were reported.No patient consequences occurred.

Manufacturer Narrative

Device eval by mfr: the ekos device was returned for analysis.The device was received tangled and tightly coiled with blood present in the coolant and drug lines.Syringes were attached to every lumen and still holding fluids.The catheter was drained and then decontamination began.The device was inspected for any damage or irregularities.Slightly wavy lines were noted the length of the infusion catheter.A kink was found at the strain relief and 124.4 cm from the strain relief.Of 15 drug pores 13 were occluded with blood matter leaving 02 drug pores open.During the air test only two drug pores produced bubbles.When run on the in-house infusion pump the pump alarmed with 5ml/hr at 15 seconds.The pump was reset at 20ml/hr and alarmed at 2 minutes.It was considered likely that the kinks were secondary findings attributable to procedural issues.

Event Description

It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic endovascular device was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After catheter placement, the patient was moved to the intensive care unit (icu).Shortly after arrival to the icu, the hospital supplied infusion pump alarmed with a downstream occlusion to the drug line on both infusion pumps.Stopcocks and roller clamps were reported to be open.No catheter kinks were noted.The user flushed the line with a 10c and a 3cc syringe for no resolution.The drug infusion pump was also replaced and the alarm continued.All troubleshooting steps were exhausted.The physician decided to bring the patient back to the catheterization lab for catheter replacement.No further issues were reported.No patient consequences occurred.

Manufacturer Narrative

Device eval by mfr: the ekos device was returned for analysis.The device was received tangled and tightly coiled with blood present in the coolant and drug lines.Syringes were attached to every lumen and still holding fluids.The catheter was drained and then decontamination began.The device was inspected for any damage or irregularities.Slightly wavy lines were noted the length of the infusion catheter.A kink was found at the strain relief and 124.4 cm from the strain relief.Of 15 drug pores 13 were occluded with blood matter leaving 02 drug pores open.During the air test only two drug pores produced bubbles.When run on the in-house infusion pump the pump alarmed with 5ml/hr at 15 seconds.The pump was reset at 20ml/hr and alarmed at 2 minutes.It was considered likely that the kinks were secondary findings attributable to procedural issues.

Event Description

It was reported that a drug occlusion occurred resulting in catheter replacement.An ekosonic endovascular device was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After catheter placement, the patient was moved to the intensive care unit (icu).Shortly after arrival to the icu, the hospital supplied infusion pump alarmed with a downstream occlusion to the drug line on both infusion pumps.Stopcocks and roller clamps were reported to be open.No catheter kinks were noted.The user flushed the line with a 10c and a 3cc syringe for no resolution.The drug infusion pump was also replaced and the alarm continued.All troubleshooting steps were exhausted.The physician decided to bring the patient back to the catheterization lab for catheter replacement.No further issues were reported.No patient consequences occurred.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12660517
• MDR Text Key: 277353833
• Report Number: 2134265-2021-13129
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 8035041341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/29/2021; 03/08/2022
• Supplement Dates FDA Received: 12/20/2021; 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other