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	10/24/2020
Type of Reportable Event	Malfunction
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 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilation.However, on initial inflation at about 15 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning at the distal balloon bond and extending approximately 12mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues.A visual and tactile examination identified that the shaft was kinked at approximately 110mm proximal of the proximal balloon bond.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.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 the moderately tortuous and moderately calcified vessel.A ss/3.5-10/4t/90 symmetry balloon catheter was advanced for dilation.However, on initial inflation at 15 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and patient status was good.

• 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: 10837240
• Report Number: 2134265-2020-15598
• Device Sequence Number: 4090060
• 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): 12/03/2020

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: 03/02/2023
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0025290822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: GUIDEWIRE: KYOUSHANT18; GUIDEWIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEF; INFLATION DEVICE: FUJI MEDICAL INDEF; INTRODUCER SHEATH: TERUMO 5FR; INTRODUCER SHEATH: TERUMO 5FR; GUIDEWIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEF; INTRODUCER SHEATH: TERUMO 5FR