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

Model Number H74939031602210

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

Patient Problem Intimal Dissection (1333)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

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)(4) clinical study. It was reported that vessel dissection occurred. In (b)(6) 2017, clinical status assessment identified the patient¿s qualifying condition as rutherford category 2. The index procedure was performed on the same day. The target lesion was located in the left superficial femoral artery had 99% stenosis, reference vessel diameter of 4. 76 mm, a length of 180 mm, and was classified as a tasc ii c lesion. The lesion was treated with pre-dilatation using 5 mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with a 6. 0mmx220mmx150cm (4f) sterling¿ balloon catheter to treat the target lesion. Post deployment of sterling¿ pta balloon, dissection b was noted and no action was taken for the same. Two days post procedure, the patient was discharged on aspirin and clopidogrel.

• 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: 7289994
• MDR Text Key: 100717108
• Report Number: 2134265-2018-01295
• Device Sequence Number: 1
• Product Code: LIT
• 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,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: H74939031602210
• Device Catalogue Number: 39031-60221
• Device Lot Number: 20481357
• 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: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/22/2018 Patient Sequence Number: 1