MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS

Model Number H74939032602210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was not received for analysis. The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling. (b)(4).

Event Description

(b)(6) study. It was reported that dissection occurred. In (b)(6) 2018, the subject¿s qualifying condition as rutherford category 2. In (b)(6) 2018 the index procedure was performed. Target lesion #1 was located in the right superficial femoral artery (sfa) had 99% stenosis, reference vessel diameter of 6 mm, a length of 110 mm, and tasc ii lesion classification was unknown. Target lesion #1 was treated with pre-dilatation using 6 mm x 220 mm balloon and standard percutaneous transluminal angioplasty (pta) was performed with 6 mm x 220 mm sterling¿ balloon. Post- dilatation was performed using 6 mm x 220 mm balloon and following this, a grade 'd' dissection was noted. Grade d dissection was treated with bare metal stent bailout. The event was considered recovered/resolved.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7647970
• MDR Text Key: 112699479
• Report Number: 2134265-2018-05728
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2019
• Device Model Number: H74939032602210
• Device Catalogue Number: 39032-60221
• Device Lot Number: 22078445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/28/2018 Patient Sequence Number: 1