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

Model Number 23295

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a pinhole located approximately 6mm distal of the distal markerband in the distal balloon sleeve.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 28-nov-2019.It was reported that balloon leak occurred.The target lesion was located in the severely tortuous and mildly calcified vein.A 3.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, the pressure did not increase during first inflation.Physician removed and checked the balloon, it was confirmed that a liquid leakage was seen in the tip side.The procedure was completed with another device.There were no patient complications reported.However, returned device analysis revealed balloon pinhole.

• 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: 9454040
• MDR Text Key: 176230404
• Report Number: 2134265-2019-15429
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729181675
• UDI-Public: 08714729181675
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0022915598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2018
• 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