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

Model Number H74939031601610

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

Patient Problems Intimal Dissection (1333); Embolism (1829)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that vessel dissection occurred.In (b)(6) 2017, index procedure was performed.The target lesion was located in the left superficial femoral artery which had 100% stenosis, reference vessel diameter of 6.5mm, a length of 95mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation using 5mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with 6.0mmx150mmx150cm (4f) sterling¿ balloon catheter.Following this intervention, grade b dissection was noted.Post dilatation was also performed and complication was resolved.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that no embolism occurred after standard percutaneous transluminal angioplasty (pta).It was confirmed that the dissection noted post standard pta treatment and after post-dilatation were the same and the complication was not resolved.

Manufacturer Narrative

Describe event or problem, and patient codes updated.Bsc id: (b)(4).Tw#: (b)(4).

Event Description

It was further reported that during the index procedure, an embolism was also noted which was then treated with thrombus aspiration.

• 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: 6732030
• MDR Text Key: 80671829
• Report Number: 2134265-2017-07367
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H74939031601610
• Device Catalogue Number: 39031-60161
• Device Lot Number: 19232883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 08/28/2017
• Supplement Dates FDA Received: 08/03/2017; 09/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR