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	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in a moderately tortuous and moderately calcified vessel.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at below nominal pressure, the balloon ruptured immediately after inflation was started.The device was removed, and the procedure was completed with a different device.There were no complications reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
D4: lot number: updated from 0029084936 to 29144422.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in a moderately tortuous and moderately calcified vessel.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at below nominal pressure, the balloon ruptured immediately after inflation was started.The device was removed, and the procedure was completed with a different device.There were no complications reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
D4: lot number: updated from 0029084936 to 29144422.Device evaluated by mfr: sv/5.5-4/4t/90 was received for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure of 15 atmospheres for 30 seconds using digital timer and deionized water without issue.A vacuum was then applied.The inflation device was verified at 15 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 15 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found no damage or issues with shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in a moderately tortuous and moderately calcified vessel.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at below nominal pressure, the balloon ruptured immediately after inflation was started.The device was removed, and the procedure was completed with a different device.There were no complications reported and the patient was in good condition post-procedure.

• 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: 17721175
• Report Number: 2124215-2023-49324
• Device Sequence Number: 7213075
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 03/30/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029144422
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 10/23/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/09/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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