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

Model Number	23335
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in an arteriovenous graft loop shunt in the mildly tortuous and moderately calcified vessel in the forearm.A 4.0-10/4t/90 symmetry balloon catheter was advanced for dilation.However, during fourth inflation at 15 atmospheres for 30 seconds, the balloon ruptured vertically.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was in good condition.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: a symmetry device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from the inner shaft and coming out of the tip.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified inner shaft damage 50mm proximal from the distal markerband.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in an arteriovenous graft loop shunt in the mildly tortuous and moderately calcified vessel in the forearm.A 4.0-10/4t/90 symmetry balloon catheter was advanced for dilation.However, during fourth inflation at 15 atmospheres for 30 seconds, the balloon ruptured vertically.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was in good condition.

• Brand Name: SYMMETRY STIFF SHAFT
• 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: 16726403
• Report Number: 2124215-2023-17061
• Device Sequence Number: 7226316
• Product Code: LIT
• UDI-Device Identifier: 08714729182757
• UDI-Public: 08714729182757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• 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): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0029495011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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
• Patient Sex: Unknown