MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Codes	Entrapment of Device (1212); Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The stenosed target lesions were located in the posterior tibial artery and superficial femoral artery (sfa) in the right leg.A 6.0mmx100mmx135cm sterling balloon catheter was selected for use.The balloon was prepared and flushed with saline.The device was then advanced through the v-18 guide wire inside the sfa and was inflated once.However, it was noticed that there was a little tough wire movement in the balloon.The balloon was inflated again but failed to inflate.It was noted that the balloon passage was kinked from the proximal part because the v-18 guide wire got stuck inside the balloon.The devices were slowly removed together and the procedure was completed with another sterling balloon catheter.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that catheter entrapment occurred.The stenosed target lesions were located in the posterior tibial artery and superficial femoral artery (sfa) in the right leg.A 6.0mmx100mmx135cm sterling balloon catheter was selected for use.The balloon was prepared and flushed with saline.The device was then advanced through the v-18 guide wire inside the sfa and was inflated once.However, it was noticed that there was a little tough wire movement in the balloon.The balloon was inflated again but failed to inflate.It was noted that the balloon passage was kinked from the proximal part because the v-18 guide wire got stuck inside the balloon.The devices were slowly removed together and the procedure was completed with another sterling balloon catheter.No patient complications were reported and the patient status was stable.Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink 17.8cm from the hub.Microscopic examination revealed no additional damages.The balloon did not inflate and a leak was noticed coming from the strain relief.The strain relief was removed and the hub separated from the shaft.The guide wire used in the clinical procedure was not returned with the device.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7961497
• Report Number: 2134265-2018-61883
• Device Sequence Number: 1682230
• Product Code: DQY
• UDI-Device Identifier: 08714729123682
• UDI-Public: 08714729123682
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K053116
• 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): 12/06/2018

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: 10/31/2018
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0018560116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 85