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

Model Number 7133

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the emerge mr balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks in the hypotube.There was a complete separation of hypotube at 24.3cm distal of the strain relief.There was contrast present in shaft as well as blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 02apr2021.It was reported that shaft kink occurred and advancing difficulties were encountered.The target lesion was located in the distal section of the left anterior descending artery.After a guidewire crossed the lesion, a 2.00mm x 15mm emerge balloon catheter was selected for use.However, the balloon shaft was kinked and could not reach the lesion during delivery.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed shaft break.

• 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: 11733741
• MDR Text Key: 247572393
• Report Number: 2134265-2021-05352
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0025309754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• 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: 57 YR
• Patient Weight: 85