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

Model Number 7163

Device Problems Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was unable to cross the lesion and the shaft got kinked.The physician had to abort the procedure due to the patient condition.The patient condition as of reporting is now stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.At 9mm proximal from the rapid port exchange, the hypotube and shaft were kinked in the same location.There was contrast present in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no further damage or irregularities.Product analysis confirmed the reported kink as the shaft and hypotube were kinked in the same location.

Event Description

It was reported that the procedure was cancelled.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was unable to cross the lesion and the shaft got kinked.The physician had to abort the procedure due to the patient condition.The patient condition as of reporting is now stable.It was further reported that the patient had severe stenosis and was sent for coronary artery bypass surgery (cabg).Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.At 9mm proximal from the rapid port exchange, the hypotube and shaft were kinked in the same location.There was contrast present in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no further damage or irregularities.Product analysis confirmed the reported kink as the shaft and hypotube were kinked in the same location.The reported no cross in the lesion could not be confirmed because the clinical circumstances could not be replicated.

• Brand Name: 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18000468
• MDR Text Key: 327271720
• Report Number: 2124215-2023-57741
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0030810326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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 Age: 67 YR
• Patient Sex: Male