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

Model Number 23295

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vessel in the left hand.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during inflation, the pressure did not rise at all and the usage was stopped.Upon pulling out the device and verified, there was a possibility of a balloon rupture.The procedure was successfully completed with a different device.No patient complications nor injuries were reported.

Event Description

It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vessel in the left hand.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during inflation, the pressure did not rise at all and the usage was stopped.Upon pulling out the device and verified, there was a possibility of a balloon rupture.The procedure was successfully completed with a different device.No patient complications nor injuries were reported.

Manufacturer Narrative

(a2) age at time of event: 18 years or older.(e1) initial reporter city: (b)(6).Device evaluated by mfr.: a symmetry device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure of 15 atmospheres.A pinhole leak on the surface of the distal balloon bond was identified.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from damage.No issues were noted which may have potentially contributed to the complaint incident.

• Brand Name: SYMMETRY
• 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: 13733304
• MDR Text Key: 287337718
• Report Number: 2134265-2022-02298
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: 08714729181897
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143193
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• 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: 0027860629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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
• Patient Sex: Female