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

Model Number	23295
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a dialysis graft in the upper extremity.An sv/6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, post-dilatation, it was noted that the shaft broke on a portion outside of the patient's body.Dilation was finished at that point, so the device was removed from the patient.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a dialysis graft in the upper extremity.An sv/6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, post-dilatation, it was noted that the shaft broke on a portion outside of the patient's body.Dilation was finished at that point, so the device was removed from the patient.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used (b)(6).2019 as event date since the correct date was not provided.Device evaluated by mfr: the device was received in two sections as a result of a complete break of the shaft.The distal balloon section of the device was received still loaded on to the customer's guidewire and gripped in a pair of forceps.Visual and tactile examination found a complete break of the shaft located at the proximal balloon bond of the device.A kink on the shaft of the device was also noted located approximately 480mm distal of the strain relief.Visual examination of the returned device identified that the balloon had been inflated.The balloon material was found to be severely bunched.Visual and microscopic examination found damage to the tip.Visual and microscopic examination found no issue with the markerbands that could have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8524460
• Report Number: 2134265-2019-03856
• Device Sequence Number: 1884290
• Product Code: LIT
• UDI-Device Identifier: 08714729181972
• UDI-Public: 08714729181972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 11/20/2020
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0021417932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1