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

Model Number 7135

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/10/2021

Event Type  malfunction  

Event Description

It was reported that a balloon rupture, removal difficulties and balloon detachment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced over a marvel guidewire.The emerge balloon catheter was inflated and the balloon ruptured on the initial inflation.The emerge balloon catheter was pulled back but it was stuck in the lesion.The emerge balloon catheter was able to be pulled back and balloon damage was observed.The marvel guidewire was removed and a piece of the emerge balloon was noticed on the marvel guidewire.Another device of a different model was used to complete the procedure.No patient complications nor injuries were reported.

Event Description

It was reported that balloon rupture and balloon detachment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for dilatation.However, during initial inflation, the balloon ruptured.The device was deflated and pulled back but it was stuck in the lesion.It was then noted that the balloon was damaged.The device was replaced with another unspecified bsc balloon catheter that failed to advance.The physician removed the marvel guidewire and noticed a piece of the first balloon was on the wire.Another wire was placed and the procedure was completed.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluation by mfr: returned product consisted of an emerge mr balloon catheter and its original sleeve packaging as well as the bsc guidewire (marvel) reported used during the procedure.The emerge device was microscopically and visually examined.At 140cm from the strain relief the shaft (inflation and guidewire lumen) was separated.The inflation lumen was buckled for a length of 1mm at 139cm from the strain relief.The returned guidewire (marvel) was measured with a laser micrometer to verify correct sizing.The guidewire contained the distal portion of the separated device.For a length of 30.2cm, measuring from the proximal end of the guidewire lumen to the tip of the device, was stretched down.The markerbands were both present on the guidewire lumen.The balloon was found on the returned guidewire damaged and accordioned with a total length of 3mm.With the damage to the balloon being severe, no further analysis to the balloon was performed to prevent further damage.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11419020
• MDR Text Key: 234956346
• Report Number: 2134265-2021-01966
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806417
• UDI-Public: 08714729806417
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0026182966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1