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

Model Number 24690

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The chronic totally occluded 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 6.0 mm x 220 mm x 150cm (4f) sterling balloon catheter was advanced for dilatation.However, after balloon angioplasty was performed, the physician tried to remove the device but resistance was felt.The device was tried to removed from being caught, but it could not easily be removed.The physician was finally able to removed the device by extending the shaft.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was functionally tested and no issues detected.The outer shaft was stretched down starting 76.2cm from the strain relief.The damaged shaft measured 77.5cm long and ended at the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that removal difficulties were encountered.The chronic totally occluded 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 6.0mm x 220mm x 150cm (4f) sterling balloon catheter was advanced for dilatation.However, after balloon angioplasty was performed, the physician tried to remove the device but resistance was felt.The device was tried to removed from being caught, but it could not easily be removed.The physician was finally able to removed the device by extending the shaft.The procedure was completed with another of the same device.No patient complications nor injuires were reported.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8846687
• MDR Text Key: 152812678
• Report Number: 2134265-2019-09041
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729859659
• UDI-Public: 08714729859659
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• 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: 09/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2020
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022556456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1