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 Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during first inflation at 4 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr.: the 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.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 2mm proximal of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination found no issue with the tip of the device.A visual and microscopic examination found no issue with the markerbands that could have potentially contributed to the complaint incident.A visual and tactile examination found no kinks or other damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, during first inflation at 4 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient serious injury or adverse event were 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: 9196867
• Report Number: 2134265-2019-12547
• Device Sequence Number: 3031032
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 05/30/2022
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0023884706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1