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

Model Number 24700

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft hole/perforation occurred.The 50% stenosed target lesion was located in the severely tortuous and mildly calcified shunt anastomosis vessel.A 6.0mmx40mmx40cm sterling balloon catheter was advanced for dilatation.Before dilatation was performed, the guidewire was removed from the device and tried to perform angiography by injecting contrast via the wire lumen of this device.However, when contrast was injected into the wire lumen, the balloon became visible, and it was noticed that there was a hole in the wire lumen and contrast flowed into the inflation lumen from that hole.The procedure was completed with a different device.No patient serious injury or adverse event were reported.

Event Description

It was reported that shaft hole/perforation occurred.The 50% stenosed target lesion was located in the severely tortuous and mildly calcified shunt anastomosis vessel.A 6.0mmx40mmx40cm sterling balloon catheter was advanced for dilatation.Before dilatation was performed, the guidewire was removed from the device and tried to perform angiography by injecting contrast via the wire lumen of this device.However, when contrast was injected into the wire lumen, the balloon became visible, and it was noticed that there was a hole in the wire lumen and contrast flowed into the inflation lumen from that hole.The procedure was completed with a different device.No patient serious injury or adverse event were reported.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated b mfr: returned product consisted of a sterling over the wire balloon catheter.The balloon was loosely folded with blood in the balloon and shaft.Analysis of the tip, balloon, markerbands, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a hole in the inner shaft/lumen located 13.2 cm from the tip, and there were numerous small kinks in the shaft.Inspection of the rest of the device found no other damage or defect.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9774588
• MDR Text Key: 181632112
• Report Number: 2134265-2020-02325
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729123781
• UDI-Public: 08714729123781
• Combination Product (y/n): N
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0024028381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1