MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7212
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon ruptured, tip detachment and difficulty in removal occurred.A 6f al1 guide was engaged in the saphenous vein graft (svg) to obtuse marginal (om).A non boston scientific wire was advanced to the distal portion on the draft into the om branch.The 95% in-stent restenotic lesion was dilated with a 2.25 x 15mm balloon wit 60% residual.Using a opticross 60mhz catheter, performed intravascular ultrasound to assess the vessel size and lesion morphology.Then dilated and stented a downstream lesion in the om branch, ultimately placing a non boston scientific stent in the om, post-dilated to 3.0mm with excellent angiographic result.Return treatment of the proximal graft in-stent restenotic lesion, using a 3.5 x 15mm nc balloon to dilate the lesion at high pressure with 30% residual.A non boston scientific stent was placed to cover the proximal graft stenosis and post dilated with a 5.00mm x 12mm nc emerge balloon catheter , however, during procedure at 20 atmospheres the balloon ruptured.Tried to remove the balloon, but it was stuck in the guide tip.Visualization of the balloon markers inside the guide, but there was a faint filling defect at the guide tip when injected contrast and performed a coronary angiogram.Of note, no filling defect was noted within the length of the svg or the distal om branch.Attempted to pull the balloon back further, but the balloon tip separated from the balloon catheter shaft; the balloon markers remained inside the tip of the guide.The guide was pulled out from the body with the balloon.On inspection of the guide after removal from the body, it was identified that the balloon material was essentially stripped and everted from the shaft of the balloon catheter, and remained stuck at the very tip of the balloon catheter and, this mass was wedged at the guide tip.The rest of the balloon catheter was inside of the guide.Re-engaged with a new 6f al1 guide angiography did not disclose a filling defect in the svg or distal om vasculature to suggest an embolized balloon fragment, so a new non boston scientific's wire and performed ivus.Ivus demonstrated a very focal defect at the distal margin of the newly placed stent in the svg.This site was at least 10-15mm further distal than the final balloon inflation with rupture but still, could not conclude if the ivus image/defect could represent a small fragment of balloon or perhaps an uplifted stent strut.Attempted to address the defect by inflating a new 5.0mm balloon at that site; but the appearance by ivus did not meaningfully change therefore, covered the lesion with an additional non boston scientific stent that is distally overlapping the first stent, thereby exteriorizing the filling defect from the lumen.After 5.0mm nc post-dilatation of the additional stent, final ivus did not show any residual evidence of luminal irregularity, with optimal stent expansion and apposition throughout.There was less than 10% residual stenosis and timi-3 flow throughout at the conclusion of the procedure.The patient recovered uneventfully from the procedure and after three days a repeat angiography of the svg to om again showed an excellent angiographic result.
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.
Event or Problem Description
It was reported that balloon ruptured, tip detachment and difficulty in removal occurred.A 6f al1 guide was engaged in the saphenous vein graft (svg) to obtuse marginal (om).A non boston scientific wire was advanced to the distal portion on the draft into the om branch.The 95% in-stent restenotic lesion was dilated with a 2.25 x 15mm balloon wit 60% residual.Using a opticross 60mhz catheter, performed intravascular ultrasound to assess the vessel size and lesion morphology.Then dilated and stented a downstream lesion in the om branch, ultimately placing a non boston scientific stent in the om, post-dilated to 3.0mm with excellent angiographic result.Return treatment of the proximal graft in-stent restenotic lesion, using a 3.5 x 15mm nc balloon to dilate the lesion at high pressure with 30% residual.A non boston scientific stent was placed to cover the proximal graft stenosis and post dilated with a 5.00mm x 12mm nc emerge balloon catheter , however, during procedure at 20 atmospheres the balloon ruptured.Tried to remove the balloon, but it was stuck in the guide tip.Visualization of the balloon markers inside the guide, but there was a faint filling defect at the guide tip when injected contrast and performed a coronary angiogram.Of note, no filling defect was noted within the length of the svg or the distal om branch.Attempted to pull the balloon back further, but the balloon tip separated from the balloon catheter shaft; the balloon markers remained inside the tip of the guide.The guide was pulled out from the body with the balloon.On inspection of the guide after removal from the body, it was identified that the balloon material was essentially stripped and everted from the shaft of the balloon catheter, and remained stuck at the very tip of the balloon catheter and, this mass was wedged at the guide tip.The rest of the balloon catheter was inside of the guide.Re-engaged with a new 6f al1 guide angiography did not disclose a filling defect in the svg or distal om vasculature to suggest an embolized balloon fragment, so a new non boston scientifics wire and performed ivus.Ivus demonstrated a very focal defect at the distal margin of the newly placed stent in the svg.This site was at least 10-15mm further distal than the final balloon inflation with rupture but still, could not conclude if the ivus image/defect could represent a small fragment of balloon or perhaps an uplifted stent strut.Attempted to address the defect by inflating a new 5.0mm balloon at that site; but the appearance by ivus did not meaningfully change therefore, covered the lesion with an additional non boston scientific stent that is distally overlapping the first stent, thereby exteriorizing the filling defect from the lumen.After 5.0mm nc post-dilatation of the additional stent, final ivus did not show any residual evidence of luminal irregularity, with optimal stent expansion and apposition throughout.There was less than 10% residual stenosis and timi-3 flow throughout at the conclusion of the procedure.The patient recovered uneventfully from the procedure and after three days a repeat angiography of the svg to om again showed an excellent angiographic result.It was further reported that the target lesion was 95% stenosed, moderately calcified and mildy tortuous.The balloon was inflated thrice and it was inflated at 14 atmospheres for 20 seconds, at 28 atmospheres for 40 seconds and 20 atmospheres for 20 seconds respectively.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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: 15297852
• Report Number: 2124215-2022-32603
• Device Sequence Number: 6050056
• Product Code: LOX
• UDI-Device Identifier: 08714729846451
• UDI-Public: 08714729846451
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0029273395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White