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

Model Number 23295

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt the mildly tortuous and mildly calcified vessel.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the second inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt the mildly tortuous and mildly calcified vessel.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the second inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was attached to an encore inflation device and positive pressure was applied, however the balloon did not inflate.The device was soaked in the waterbath at 37 degrees celsius to soften hardened medium or blood that may have been present in the device.The device was removed from the bath and was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified at the distal end of the proximal marker band.No other issues were noted.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.The rated burst pressure for this device is 15 atmospheres.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SYMMETRY
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9521515
• MDR Text Key: 177127657
• Report Number: 2134265-2019-16188
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: 08714729181897
• Combination Product (y/n): N
• PMA/PMN Number: K143193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023857094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1