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

Model Number	23335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in the left hand.A 3.5-10/4t/90 symmetry balloon catheter was advanced for dilatation.However, during inflation at nominal pressure for a few seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(e1) initial reporter city: (b)(6).Device evaluated by mfr: received a symmetry device.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 balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located 17mm proximal from the distal tip.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 a shaft kink 9mm distal from the distal end of the hub.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in the left hand.A 3.5-10/4t/90 symmetry balloon catheter was advanced for dilatation.However, during inflation at nominal pressure for a few seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: SYMMETRY STIFF SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11562091
• Report Number: 2134265-2021-03804
• Device Sequence Number: 16882980
• Product Code: LIT
• UDI-Device Identifier: 08714729182665
• UDI-Public: 08714729182665
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 01/04/2024
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0026574558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1