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

Model Number 24690

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0mmx100mmx150cm (4f) sterling balloon catheter was advanced for dilatation however, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.There was blood in the inflation lumen.The balloon was torn 5cm on proximal end of the balloon.There was no other damage or irregularities with the device.

Event Description

It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0mmx100mmx150cm (4f) sterling balloon catheter was advanced for dilatation however, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications 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: 9406990
• MDR Text Key: 174584434
• Report Number: 2134265-2019-14884
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729859581
• UDI-Public: 08714729859581
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2020
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022358528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2019
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1