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

Model Number	23295
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and catheter separation occurred which requires additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified radial artery.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.During the procedure, the non-boston scientific sheath was placed in the vein.However, upon inflation at 17 atmospheres beyond anastomosis, the balloon ruptured, and the balloon part got separated inside the catheter.Upon removal, resistance was felt and the device got caught on the sheath.Consequently, the device was removed surgically as a single unit with the sheath.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device was returned for evaluation.The device was returned advanced through a 6fr sheath.As per specification, this device is compatible with a 5fr sheath.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 3 mm proximal of the proximal markerband.A visual and tactile examination found the shaft of the device to be severely stretched and buckled between the proximal and distal markerbands.A complete separation of the shaft was also identified located at the distal balloon bond.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20471209
• Report Number: 2124215-2024-62442
• Device Sequence Number: 17980166
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: 05/16/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029413719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: VAIVT ACE 6FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown