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

Model Number 23295

Device Problem Material Rupture (1546)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a shunt in a moderately tortuous and severely calcified vessel in the upper arm.A 4.5-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, during initial inflation at about 12 atmospheres for about 5 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was good.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a shunt in a moderately tortuous and severely calcified vessel in the upper arm.A 4.5-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, during initial inflation at about 12 atmospheres for about 5 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was good.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated by manufacturer: a symmetry device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from the shaft that was noted to be damaged located approximately 8mm proximally from the proximal balloon bond.The balloon was unable to fully inflate due to the shaft leak.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.

• 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: 14429500
• MDR Text Key: 291931599
• Report Number: 2134265-2022-05642
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: 0028799271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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