MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE¿ 26; SYRINGE, BALLOON INFLATION

Model Number M001151050

Device Problems Break (1069); Inflation Problem (1310); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

Malfunctioning equipment.Either the balloon broke on stent or the insufflator malfunctioned.Procedural note: initial left common femoral artery access was obtained with the use of b-mode ultrasound imaging.The artery was noted to be patent under ultrasound guidance, and a micro access needle and wire were placed.This was saved to pacs.This was followed by the placement of an 0.035 wire through the micro access sheath and a 5-french sheath with the use of a short berenstein catheter and glidewire, the wire was placed at the abdominal aorta followed by omniflush catheter and aortogram with bilateral iliac angiogram was performed which noted near occlusive nature of the catheter within the left iliac artery consistent with a high grade proximal stenosis.A retrograde iliac angiogram showed patency of the remainder of the iliac system.This decision was made to access the right femoral artery, which was imaged with b-mode ultrasound imaging noted be patent.Followed by placement of micro access needle and wire under ultrasound guidance and images were saved to pacs.Over the micro access sheath and 0.035 wire was placed in the abdominal aorta followed by a 5-french sheath.Again, omniflush catheter was placed via the right femoral access and aortogram revealed a stentable proximal lesion on the left.Secondary to this, the patient was fully heparinized.After full heparinization, amplatz wires were placed bilaterally in the aorta through the sheath followed by the placement of 23 cm 7-french sheaths.Again, a magnified aortogram was performed.In order to pass the stenoses proximally on the left, in particular the iliac lesion was dilated with a 6 x 2 mm balloon followed by the placement of a 7-french sheath which was passed into the distal aorta two 7 x 60 mm icast stents were deployed sequentially.Of note, upon inflating of the right icast sheath a question of the balloon breaking secondary to inability to completely insufflate this area the balloon catheter was removed.The sheath remained in place under fluoroscopic guidance.A 7 x 2 mm balloon was then brought through this and dilated in a kissing fashion with a 6 x 2 mm balloon in the left to completely expand both sheaths.A completion aortogram showed the above findings with a question of a likely occlusive distal aortic shelf of plaque.Second to this, the decision was made to place additional stents into the distal abdominal aorta.A 7 x 29 vbx sheath was then brought to the distal aorta and deployed in a kissing fashion under of the large lumbar branch which was previously marked with aortogram.Once they were deployed, catheters were removed followed by another antegrade aortogram which showed findings above.There was no need for additional intervention secondary to the small size of the infrarenal aorta, the decision was made to perform intravascular ultrasound post-stent deployment initially performed over an 0.018 wire via the right access which showed a patent proximal stent with mild to moderate compression but no indication for further stenting.This was also performed in the aorta which showed a patent distal aorta.This was also performed via the left iliac stent, which showed a mild proximal compression but widely patent and no finding of any dissection or extravasation via the aortogram or the intravascular ultrasound with the remaining left lateral plaque in the aorta.Decision made for no further intervention.All wires were removed.Sheaths were removed and direct pressure was held for hemostasis.The patient was reversed with 30 mg of protamine.After direct pressure was held, sterile dressings were placed.The patient was transferred to postop in stable condition after extubation.

• Brand Name: ENCORE¿ 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8594880
• MDR Text Key: 144551011
• Report Number: 8594880
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: (01)08714729183624(17)201126(10)22994953
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001151050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 55