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

Device Problem Material Rupture (1546)

Patient Problems Arrhythmia (1721); Hematoma (1884); Vascular Dissection (3160)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study.It was reported that balloon rupture occurred.In (b)(6) 2019, the right sfa was treated with a 6.00mm sterling balloon which ruptured.Hence a 6mm non-bsc balloon was used to treat the lesion followed by 8mm sterling balloon catheter.Following this, disassociation and hematomas were noted.Subsequently, the lesion was treated 6mm x 120mm non-bsc balloon and post dilation with a 6mm balloon.

Manufacturer Narrative

Initial reporter city: (b)(6).Updated describe event or problem.

Event Description

(b)(6) clinical study it was reported that balloon rupture occurred.In (b)(6) 2019, the right superficial femoral artery (sfa) was treated with a 6.00mm sterling balloon which ruptured.Hence a 6mm non-bsc balloon was used to treat the lesion followed by 8mm sterling balloon catheter.Following this, disassociation and hematomas were noted.Subsequently, the lesion was treated 6mm x 120mm non-bsc balloon and post dilation with a 6mm balloon.It was further reported that the 75% stenosed right sfa 8mm sterling balloon catheter was used to treat the right common femoral artery.Following this, grade c dissection occurred.On the same day, the events were considered recovered/resolved.Two days after, the patient was discharged.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8499719
• MDR Text Key: 141470621
• Report Number: 2134265-2019-03642
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR