MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 23295

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and mildly calcified vein anastomosis.A 4.5-4/4t/40 symmetry balloon catheter was selected for use.However, during preparation, after opening the seal and removing the protective sheath attached to the balloon, it was noticed that the balloon material detached from the shaft.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated by mfr.: a symmetry device was returned for analysis.The balloon section, markerbands and tip was received detached from the shaft and was still inserted in the balloon protector.A visual examination identified that the balloon was folded which indicates that the balloon was not subjected to positive pressure.No other issues were identified with the balloon material.A visual and tactile examination of the shaft identified a shaft break 365mm distal from the distal end of the hub.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.This concludes the product analysis.

Event Description

It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and mildly calcified vein anastomosis.A 4.5-4/4t/40 symmetry balloon catheter was selected for use.However, during preparation, after opening the seal and removing the protective sheath attached to the balloon, it was noticed that the balloon material detached from the shaft.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

• Brand Name: SYMMETRY 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14229247
• MDR Text Key: 290256945
• Report Number: 2134265-2022-04333
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027504184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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