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

Model Number	23295
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and detachment occurred requiring additional intervention.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt limb.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during initial inflation at 12 atmospheres, the balloon ruptured immediately.A rupture was identified, and deflation was performed several times.During removal, the balloon was stuck on the tip of the sheath and could not be removed properly.An attempt was made to remove the balloon while rotating it, but only the balloon catheter was removed while being lifted and balloon part was remained inside the body.A biopsy forceps was then inserted, and the balloon remnant was collected.Echocardiography confirmed that there was no retention in the body.The procedure was completed with a different device and the patient was in good condition post procedure.
Event or Problem Description
It was reported that balloon rupture and detachment occurred requiring additional intervention.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt limb.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during initial inflation at 12 atmospheres, the balloon ruptured immediately.A rupture was identified, and deflation was performed several times.During removal, the balloon was stuck on the tip of the sheath and could not be removed properly.An attempt was made to remove the balloon while rotating it, but only the balloon catheter was removed while being lifted and balloon part was remained inside the body.A biopsy forceps was then inserted, and the balloon remnant was collected.Echocardiography confirmed that there was no retention in the body.The procedure was completed with a different device and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: sv/3.5-4/4t/90 was received for analysis.A visual examination identified a complete balloon circumferential tear located approximately at the distal edge of the proximal markerband.This type of damage most probably occurred when the device was being withdrawn through the sheath.The rated burst pressure for this balloon is 15 atmospheres as per symmetry specification.A visual and tactile examination found the shaft of the device to have completely separated at a location proximal of the distal tip bond and severely stretched distal of the proximal markerband.A visual examination observed that the distal section of the device including the distal markerband, a section of balloon material, a section of shaft and tip of the device was not returned for analysis.The proximal markerband was undamaged in the correct position on the device.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16899059
• Report Number: 2124215-2023-19500
• Device Sequence Number: 5561717
• Product Code: LIT
• UDI-Device Identifier: 08714729181736
• UDI-Public: 08714729181736
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029429601
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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, 18; GUIDEWIRE, 18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male