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	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres for 10 seconds, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres for 10 seconds, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient condition was good.
Additional Manufacturer Narrative
(e1) initial reporter facility name:(b)(6) hospital device evaluated by manufacturer: a symmetry device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The rated burst pressure for this device is 15 atmospheres.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.The leak coming out from the tip, most probably occurred due to the user applying excessive force to the delivery system when loading guidewire into device.The tip of the guidewire most likely punctured the inner shaft between the inflation lumen and guidewire lumen.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no issues to the shaft of the device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13008193
• Report Number: 2134265-2021-15802
• Device Sequence Number: 1816958
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 05/24/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027376846
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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