MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number 24700

Device Problems Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528); Failure to Deflate (4060)

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

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported that deflation failure and removal difficulties occurred.The 99% stenosed, fully occluded target lesion was located in the mildly tortuous and severely calcified left superficial femoral artery (sfa).Vascular access was obtained via patent below the knee vessel.After attempting to use a mustang balloon catheter, crossing some of the tight lesions was not possible.After a.018 v-18 guidewire was crossed the lesion, a 4.0mm x 80mm x 135cm sterling balloon catheter was able to track to the distal portion of the occlusion and a contrast/saline ratio of 50/50 was applied.Multiple inflations were needed to cover the entire length of the left superficial femoral artery and external iliac artery.The device was inflated at 14 atmospheres for 10 seconds in five separate areas along the entire sfa.After these inflations the balloon was to be removed to visualize the progress.However, the sterling balloon catheter would only partially come into the sheath, and it was noticed that it was still inflated.There was also a leak at the hub when trying to aspirate the balloon.Multiple attempts were made to deflate the balloon.The device was pulled back into the 6fr non-boston scientific sheath minimally and using back end of separate wire to puncture the balloon, but it would not deflate.Eventually, the physician decided to remove the sheath and the fully inflated balloon together over the wire and patient did not feel any pain while the balloon remained inflated.A new sheath was placed, and a.018 wire was used, then the physician made another wire exchange to place a 45cm 6fr sheath to continue the procedure with no complications.The access site was able to be closed with a closure device with no complications.The procedure was completed with dilation of a.035 mustang balloon catheter and implantation of an epic stent.The patient remained stable for the entire procedure.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter stuck inside a terumo sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated from the hub.The guidewire lumen is stretched and buckled 106cm from the hub.Microscopic examination revealed that the inflation lumen is stretched 76cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

Event Description

It was reported that deflation failure and removal difficulties occurred.The 99% stenosed, fully occluded target lesion was located in the mildly tortuous and severely calcified left superficial femoral artery (sfa).Vascular access was obtained via patent below the knee vessel.After attempting to use a mustang balloon catheter, crossing some of the tight lesions was not possible.After a.018 v-18 guidewire was crossed the lesion, a 4.0mm x 80mm x 135cm sterling balloon catheter was able to track to the distal portion of the occlusion and a contrast/saline ratio of 50/50 was applied.Multiple inflations were needed to cover the entire length of the left superficial femoral artery and external iliac artery.The device was inflated at 14 atmospheres for 10 seconds in five separate areas along the entire sfa.After these inflations the balloon was to be removed to visualize the progress.However, the sterling balloon catheter would only partially come into the sheath, and it was noticed that it was still inflated.There was also a leak at the hub when trying to aspirate the balloon.Multiple attempts were made to deflate the balloon.The device was pulled back into the 6fr non-boston scientific sheath minimally and using back end of separate wire to puncture the balloon, but it would not deflate.Eventually, the physician decided to remove the sheath and the fully inflated balloon together over the wire and patient did not feel any pain while the balloon remained inflated.A new sheath was placed, and a.018 wire was used, then the physician made another wire exchange to place a 45cm 6fr sheath to continue the procedure with no complications.The access site was able to be closed with a closure device with no complications.The procedure was completed with dilation of a.035 mustang balloon catheter and implantation of an epic stent.The patient remained stable for the entire procedure.There were no patient complications reported.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14782271
• MDR Text Key: 295019472
• Report Number: 2134265-2022-06546
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0028850987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White