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

Model Number	23295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure.The balloon was inflated to its rate of burst pressure of 15 atmospheres without issue.A vacuum was then applied.The inflation device was verified at 15 atmospheres, before and after use.This inflation to rate of burst pressure of 15 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.Visual and microscopic examination found no issue with the markerbands.Visual and tactile examination found that the shaft was free from damage.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8714846
• Report Number: 2134265-2019-07192
• Device Sequence Number: 2600710
• Product Code: LIT
• UDI-Device Identifier: 08714729181675
• UDI-Public: 08714729181675
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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
• Operator of Device: 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: 07/02/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1