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

Model Number	23295
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the customer's guidewire was not returned for analysis.A visual and tactile examination of the shaft identified one severe kink approximately 95mm from the balloon bond.During analysis the investigator selected a 0.018 inch guidewire, the guidewire was inserted through the device, however minor resistance was encountered at the location of the shaft kink.This type of damage is consistent with excessive force being applied to the device.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.The returned device was attached to an 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 blood 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 blood 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 at the distal edge of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.An examination of the markerbands and tip identified no damage or any issues that could have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15nov2019.It was reported that crossing difficulties were encountered and shaft kink occurred.The target lesion was 90% stenosed and locate in the severely calcified and moderately tortuous vessel.A 3.5-4/4t/90 symmetry balloon catheter was advanced but failed to cross the lesion.The physician pushed the device but the catheter got kinked.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed balloon pinhole.

• 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: 9412405
• Report Number: 2134265-2019-14941
• Device Sequence Number: 2930517
• Product Code: LIT
• UDI-Device Identifier: 08714729181736
• UDI-Public: 08714729181736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• 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
• Report Date (Section B): 12/04/2019

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 Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023700384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1