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

Model Number 7161

Device Problems Inflation Problem (1310); Material Integrity Problem (2978)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.The inflation lumen was bubbled and stretched out for 4mm in length and 72mm from the tip of the device.The balloon was loosely folded and there was tip damage to the device.After soaking the device to remove contrast, an inflation device was connected to the inflation port.The device was inflated to 4 atmospheres (atm) to see if there was a leak in the inflation lumen where the lumen was bubbled up and stretched.Functional testing revealed shaft damage and a longitudinal shaft tear in the inflation lumen 4mm in length and 72mm from the tip of the device.The device failed to inflate to rated burst pressure as at 4atm the device was found to be leaking.

Event Description

Reportable based on device analysis completed on 01-sep-2021.It was reported that balloon slow inflation and shaft damage occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the left circumflex artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.The balloon was inflated 12 times.On the 7th inflation at 18 atmospheres for 10 seconds, the physician noticed that when inflating, the balloon did not expand at the marker and inflated at the proximal shaft of the catheter.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed longitudinal shaft tear.

• Brand Name: EMERGE
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12510474
• MDR Text Key: 272687469
• Report Number: 2134265-2021-11353
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

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: 05/12/2023
• Device Model Number: 7161
• Device Catalogue Number: 7161
• Device Lot Number: 0026009326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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: 53 YR
• Patient Weight: 37