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	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred and was removed via snaring.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified forearm cephalic vein anastomosis part.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during 4th inflation for 30 seconds, the balloon ruptured.The balloon could not be pulled into the sheath since negative pressure was not applied.Therefore, a sheath was added upward, and the device was retrieved by grasping it with a 5mm snare catheter.The procedure was completed using this device.No complications were reported, and the patient was in good condition post procedure.
Event or Problem Description
It was reported that balloon rupture occurred and was removed via snaring.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified forearm cephalic vein anastomosis part.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during 4th inflation for 30 seconds, the balloon ruptured.The balloon could not be pulled into the sheath since negative pressure was not applied.Therefore, a sheath was added upward, and the device was retrieved by grasping it with a 5mm snare catheter.The procedure was completed using this device.No complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device was returned for evaluation.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 at the proximal markerband.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 be severely stretched and buckled between the proximal and distal markerbands.A complete separation of the shaft was also identified possibly to facilitate the removal of the hub/manifold during removal of the device from the patient as the site of separation displayed evidence of being cut.The proximal section of shaft including the hub/manifold was not returned for analysis.A visual and tactile examination found no issues with the tip of the device.A visual and tactile examination found no issues with the markerbands of the device.No other issues were identified with the device and no patient complications were 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20022296
• Report Number: 2124215-2024-48528
• Device Sequence Number: 8784308
• 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,Followup
• Report Date (Section B): 09/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown