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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, the balloon ruptured after several inflations at 18 atmospheres for 30 seconds.The device was removed and the procedure was completed.There were no patient complications and the patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, the balloon ruptured after several inflations at 18 atmospheres for 30 seconds.The device was removed and the procedure was completed.There were no patient complications and the patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: symmetry sv/5.0-4/4t/90 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 1mm proximal of the distal balloon to tip bond.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13926403
• Report Number: 2134265-2022-03488
• Device Sequence Number: 11207480
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: 08714729181897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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: 11/24/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0028451349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V18 150CM BSJ; GUIDEWIRE: V18 150CM BSJ; INFLATION DEVICE: ENCORE BSJ; INFLATION DEVICE: ENCORE BSJ; INTRODUCER SHEATH: 5F MOSQUITE SHEATH; INTRODUCER SHEATH: 5F MOSQUITE SHEATH
• Patient Sex: Unknown