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

Model Number	7212
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detachment, shaft break and catheter entrapment occurred.The patient had two layers of an unknown stent that had in-stent restenosis.The 70% stenosed target lesion was located in the mildy tortuous and moderately calcified right coronary artery (rca).A 3.50mm x 12mm emerge balloon catheter was advanced for pre-dilatation of the lesion for a third layer of stent.However, during the initial inflation at 16 atm for 20 seconds, the balloon ruptured.The physician pulled the device out; however, the inner shaft of the balloon broke leaving behind the distal part of the balloon severed and stuck on the wire.A second wire was delivered to rca past the loose balloon and a second emerge balloon was placed on the second wire in order to inflate and trap the detached piece of the balloon.The detached portion was removed, and no device fragments were left inside the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There were numerous kinks to both the shaft and hypotube of the device.There was blood and contrast in the inflation lumen and the loosely folded balloon.There was blood in the guidewire lumen.At the proximal end of the bicomponent weld, the guidewire lumen was separated.At the distal end of the bicomponent weld, the guidewire lumen was buckled for a length of 8mm.At 8mm distal from the proximal waist, the balloon had a full circumferential tear.The distal portion of the balloon was prolapsed.Media depicts a full circumferential tear to the balloon, guidewire lumen detachment at bicomponent weld area and prolapsed balloon confirming the reported separation, burst, and balloon detachment.Product analysis was able to confirm the reported events as the balloon had a full circumferential tear and the guidewire lumen was separated and buckled.
Event or Problem Description
It was reported that balloon rupture, balloon detachment, shaft break and catheter entrapment occurred.The patient had two layers of an unknown stent that had in-stent restenosis.The 70% stenosed target lesion was located in the mildy tortuous and moderately calcified right coronary artery (rca).A 3.50mm x 12mm emerge balloon catheter was advanced for pre-dilatation of the lesion for a third layer of stent.However, during the initial inflation at 16 atm for 20 seconds, the balloon ruptured.The physician pulled the device out; however, the inner shaft of the balloon broke leaving behind the distal part of the balloon severed and stuck on the wire.A second wire was delivered to rca past the loose balloon and a second emerge balloon was placed on the second wire in order to inflate and trap the detached piece of the balloon.The detached portion was removed, and no device fragments were left inside the patient's body.No patient complications were reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18385906
• Report Number: 2124215-2023-73189
• Device Sequence Number: 19825464
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 09/07/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0032381323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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 Sex: Unknown