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

Model Number 7213

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported that balloon rupture, balloon detach and unretrieved device fragment lead to additional surgery occurred.The target lesion was located in the very calcified diagonal branch.A 2.5x20 emerge balloon catheter was advanced and inflated at 10atmospheres (atm).A 2.5x26 non-boston scientific (bsc) stent was then placed in the lesion and post-dilated with a 2.5x15 nc emerge balloon catheter twice at 25 atm.The balloon was removed and they proceeded to treat the lesion with shockwave and a 2.5x15 wolverine cutting balloon.A 2.75x15 nc emerge balloon catheter was then advanced and inflated at 22 atm for 100 seconds.However, the balloon ruptured and when the balloon was deflated, they suspected a possible dissection.Upon removing the balloon they realized that part of the balloon was left in the patients body.Snaring the remains of the balloon was tried but unsuccessful.The patient was then taken to surgery for a triple bypass.No further patient complications were reported.

Manufacturer Narrative

A2 age at time of event updated.A3 sex updated.A6 race updated.G2 report source updated.

Event Description

It was reported that balloon rupture, balloon detach and unretrieved device fragment lead to additional surgery occurred.The target lesion was located in the very calcified diagonal branch.A 2.5x20 emerge balloon catheter was advanced and inflated at 10atmospheres (atm).A 2.5x26 non-boston scientific (bsc) stent was then placed in the lesion and post-dilated with a 2.5x15 nc emerge balloon catheter twice at 25 atm.The balloon was removed and they proceeded to treat the lesion with shockwave and a 2.5x15 wolverine cutting balloon.A 2.75x15 nc emerge balloon catheter was then advanced and inflated at 22 atm for 100 seconds.However, the balloon ruptured and when the balloon was deflated, they suspected a possible dissection.Upon removing the balloon they realized that part of the balloon was left in the patients body.Snaring the remains of the balloon was tried but unsuccessful.The patient was then taken to surgery for a triple bypass.No further patient complications were reported.It was further reported that the detached part of the balloon was lodged in the left anterior descending artery.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15217748
• MDR Text Key: 297788464
• Report Number: 2124215-2022-30040
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028468280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White