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

Model Number 7133

Device Problem Material Deformation (2976)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: used (b)(6) 2022 as event date since the correct date was not provided.Device evaluated by mfr.Returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube.The hypotube was separated at 58cm distally from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Product analysis confirmed the reported kink as there were numerous hypotube kinks to the device.There was also an unreported hypotube separation.The separated ends were oval shaped indicating that the device was kinked prior to separation.

Event Description

Reportable based on device analysis completed on 10jan2023.It was reported that shaft kink occurred.A 3.00mm x 15mm fg emerge balloon catheter was selected for use.However, prior to procedure, the stent was noted to be kinked.The procedure was completed with a different device with no patient complications reported.However, returned device analysis revealed shaft detached/separated.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16203406
• MDR Text Key: 307678730
• Report Number: 2124215-2023-01666
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0029871719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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