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	01/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5-2/4t/90 symmetry balloon catheter was advanced for dilatation.However, during first inflation at 3 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5-2/4t/90 symmetry balloon catheter was advanced for dilatation.However, during first inflation at 3 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a sv/3.5-2/4t/90 was returned for analysis.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified at the distal end of the distal markerband.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 as per symmetry directions for use.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 issues.A visual and tactile examination identified a kink at the proximal end of the tip as it meets the balloon.No other issues were identified during the product analysis.

• 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: 9711465
• Report Number: 2134265-2020-01526
• Device Sequence Number: 353564
• Product Code: LIT
• UDI-Device Identifier: 08714729181712
• UDI-Public: 08714729181712
• 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): 03/27/2020

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: 04/23/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023689667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1