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

Model Number	23295
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and removal difficulties requiring surgical intervention occurred.The 90% stenosed target lesion was located in a shunt in a mildly tortuous and non-calcified cephalic vein.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, after several dilatation at 16 atmospheres, the balloon ruptured horizontally.Attempts were made to retrieve the device; however, the balloon portion was caught in the sheath and was not able to remove.The physician removed the balloon surgically and after it ruptured, contrast showed that the lesion was dilated, then the procedure was terminated.There were no patient complications reported and the patient status was in good condition.
Event or Problem Description
It was reported that balloon rupture and removal difficulties requiring surgical intervention occurred.The 90% stenosed target lesion was located in a shunt in a mildly tortuous and non-calcified cephalic vein.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, after several dilatation at 16 atmospheres, the balloon ruptured horizontally.Attempts were made to retrieve the device; however, the balloon portion was caught in the sheath and was not able to remove.The physician removed the balloon surgically and after it ruptured, contrast showed that the lesion was dilated, then the procedure was terminated.There were no patient complications reported and the patient status was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr: an sv/5.5-4/4t/90 symmetry balloon catheter was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 7mm distal of the proximal balloon bond.An examination of the balloon material and markerbands identified no other issues.The rated burst pressure for this device is 15 atmospheres as per symmetry specification.A visual examination found no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have accordion damage at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found both markerbands to be undamaged and present on the shaft of the device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16611218
• Report Number: 2124215-2023-10566
• Device Sequence Number: 20057205
• Product Code: LIT
• UDI-Device Identifier: 08714729181934
• UDI-Public: 08714729181934
• 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): 04/18/2023

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: 05/22/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029449429
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: FUGA; GUIDEWIRE: FUGA; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: VAIVT ACE; INTRODUCER SHEATH: VAIVT ACE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown