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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.Vascular access was obtained via the retrograde approach from the radial vein side.The 75% stenosed target lesion was located in the mildly tortuous forearm radial artery.After a 5fr 4cm non-boston scientific (bsc) guide catheter was placed and a non-bsc guidewire was crossed the lesion, pre-dilation was performed with a 3.5-4/4t/90 symmetry balloon catheter.However, on the third inflation at 16 atmospheres, the balloon ruptured.The balloon and wire were removed together from the sheath, but the tip of the balloon was noted to be missing.Subsequently, angiography was performed, but the location of the separated part could not be confirmed.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 12mm distal of the proximal balloon bond.This type of damage most probably occurred when the device was being withdrawn through the sheath.The distal section of balloon material including a section of shaft, the distal markerband and tip of the device was not returned for analysis.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.The distal section of shaft including the distal section of balloon material, the distal markerband and tip of the device was not returned for analysis.The shaft is also severely stretched distal of the proximal markerband.The distal section of the device including a section of balloon material, a section of shaft the distal markerband and tip of the device was not returned for analysis.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.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.Vascular access was obtained via the retrograde approach from the radial vein side.The 75% stenosed target lesion was located in the mildly tortuous forearm radial artery.After a 5fr 4cm non-boston scientific (bsc) guide catheter was placed and a non-bsc guidewire was crossed the lesion, pre-dilation was performed with a 3.5-4/4t/90 symmetry balloon catheter.However, on the third inflation at 16 atmospheres, the balloon ruptured.The balloon and wire were removed together from the sheath, but the tip of the balloon was noted to be missing.Subsequently, angiography was performed, but the location of the separated part could not be confirmed.The procedure was completed with no patient complications reported.

• 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: 17073952
• Report Number: 2124215-2023-25098
• Device Sequence Number: 6673349
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 05/17/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029421130
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown