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

Model Number	23335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.A 6.0-4/4t/135 symmetry stiff shaft balloon catheter was advanced for dilation.However, during the procedure, the shaft broke leaving the balloon in the patient.The broken tip was retrieved and the procedure was completed.
Event or Problem Description
It was reported that shaft break occurred.A 6.0-4/4t/135 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke leaving the balloon in the patient.The broken tip was retrieved and the procedure was completed.
Additional Manufacturer Narrative
Device evaluated by mfr: a ss/6.0-4/4t/135 was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located at the proximal balloon sleeve.The balloon material had been pushed distally towards the tip of the device.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed damage to the tip of the device.This type of damage is consistent with the excessive force being applied to the device when resistance is encountered.A visual and tactile examination found a complete break to the shaft of the device located at the proximal edge of the proximal markerband.The proximal section of shaft was found to be stretched/damaged beginning approximately at the proximal balloon sleeve and extending distally to the shaft break site.The distal section of shaft was found to have accordion damage beginning approximately at the proximal markerband and extending approximately 17mm distally along the shaft.This type of damage is consistent with the device encountering resistance and excessive tensile force being applied to the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.

• 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: 11930935
• Report Number: 2134265-2021-06740
• Device Sequence Number: 17265925
• Product Code: LIT
• UDI-Device Identifier: 08714729182931
• UDI-Public: 08714729182931
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 08/17/2021
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0022532775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR