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

Model Number	23295
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9454040
• Report Number: 2134265-2019-15429
• Device Sequence Number: 11304488
• 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
• Report Date (Section B): 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
• 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: 11/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1