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	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).(e1) initial reportercity: (b)(6).Device evaluated by mfr.: the device was returned for analysis.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.Multiple pinhole leaks were identified in the mid-section of the balloon.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.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9462539
• Report Number: 2134265-2019-15729
• Device Sequence Number: 14221140
• Product Code: LIT
• UDI-Device Identifier: 08714729181798
• UDI-Public: 08714729181798
• 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): 02/24/2020

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: 04/13/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023642194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: KYOUSHANT 18; GUIDE WIRE: KYOUSHANT 18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TEUMO 4FR; INTRODUCER SHEATH: TEUMO 4FR