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

Model Number	23335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and mildly calcified vessel.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during the third inflation at 15 atmospheres for 30 seconds, 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 inflation lumen which is evidence of a device leak.Microscopic examination identified a balloon longitudinal tear beginning at the distal balloon bond and extending for approximately 11mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues.The rated burst pressure for this balloon is 15 atmospheres as per symmetry specification.Visual and microscopic examination found no issue with the tip of the device.Visual and microscopic examination found no issue with the markerbands.Visual and tactile examination found no kinks or other damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and mildly calcified vessel.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during the third inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYMMETRY STIFF SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8751503
• Report Number: 2134265-2019-07702
• Device Sequence Number: 2398359
• Product Code: LIT
• UDI-Device Identifier: 08714729182665
• UDI-Public: 08714729182665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• 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): 08/08/2019

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: 02/28/2022
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0023423681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: GUIDEWIRE: KYOUSHANT 18; GUIDEWIRE: KYOUSHANT 18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR; INTRODUCER SHEATH: TERUMO 5FR; GUIDEWIRE: KYOUSHANT 18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR