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

Model Number 7139

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.During a percutaneous coronary intervention (pci) procedure, the target lesion was in an area of in-stent restenosis located in the tortuous and calcified left anterior descending artery.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, while trying to advance, the shaft was kinked and after several attempts, the device eventually broke.The device was pulled back and removed as a unit with no fragments left inside the patient's body.The lesion was rewired and the procedure was completed with another emerge balloon catheter.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: media provided by the facility was reviewed and indicates a separation on the device with both ends placed in a plastic bag.Returned product consisted of an fg emerge push mr, us 1.50mm x 20mm catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.Balloon was identified with tight folds.Shaft separation was identified 22.2 cm from the strain relief.Numerous kinks/bends were identified on the hypotube and shaft.Tip was also identified to be damaged.Product analysis confirms the reported event as shaft break was confirmed 22.2 cm from strain relief.

Event Description

It was reported that a shaft break occurred.During a percutaneous coronary intervention (pci) procedure, the target lesion was in an area of in-stent restenosis located in the tortuous and calcified left anterior descending artery.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, while trying to advance, the shaft was kinked and after several attempts, the device eventually broke.The device was pulled back and removed as a unit with no fragments left inside the patient's body.The lesion was rewired and the procedure was completed with another emerge balloon catheter.There were no patient complications reported.

• Brand Name: EMERGE PUSH
• Type of Device: 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: 15486438
• MDR Text Key: 300600154
• Report Number: 2124215-2022-35517
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806035
• UDI-Public: 08714729806035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7139
• Device Catalogue Number: 7139
• Device Lot Number: 0029101686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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