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

Model Number 23295

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that shaft hole was encountered.Patient underwent a shunt percutaneous transluminal angioplasty.The 50% stenosed target lesion was located in the mild tortuous and non-calcified radial vein.A 5.0-4/4t/40 symmetry balloon catheter was advanced for dilation.However, during the procedure, a pinhole damage on the shaft near the balloon part was observed.The device was replaced for a different device to complete the procedure.No complications were reported, and the patient was in good condition post-procedure.

Event Description

It was reported that shaft hole was encountered.Patient underwent a shunt percutaneous transluminal angioplasty.The 50% stenosed target lesion was located in the mild tortuous and non-calcified radial vein.A 5.0-4/4t/40 symmetry balloon catheter was advanced for dilation.However, during the procedure, a pinhole damage on the shaft near the balloon part was observed.The device was replaced for a different device to complete the procedure.No complications were reported, and the patient was in good condition post-procedure.

Manufacturer Narrative

Device evaluated by mfr.: symmetry balloon was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was inflated to its rated burst pressure of 15 atmospheres with no leaks or issues noted with the balloon material or the shaft of the device.A visual and tactile examination identified a shaft kink 50mm proximal of the distal tip.A visual examination identified no issues with the tip of the device.The reported shaft pinhole was not confirmed.

• Brand Name: SYMMETRY 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18722697
• MDR Text Key: 335596704
• Report Number: 2124215-2024-08633
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 0031161215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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