MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939147301010

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter removal difficulties were encountered and balloon tear occurred. A 3. 0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation. However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder. The guide and the balloon were removed from the patient. No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter with an unidentified guide wire still inserted. The balloon was loosely folded. There was contrast in the inflation lumen. Device analysis determined the condition of the returned device was consistent with the complaint incident. The outer shaft, inner shaft, balloon and tip were microscopically examined. There were numerous hypotube kinks. There was tip damage. The wire lumen inside the balloon was buckled. The shaft was completely separated 134. 5cm from the hub. The fracture faces were stretched prior to separation. Functional testing for balloon leak through inflation could not be conducted due to the shaft separation. Visual inspection of the balloon did not reveal any damages. The inner and outer lumen was torn at the exit notch and could contribute to the balloon leak. The guide wire was successfully removed from the distal portion of the detached catheter. The guide wire was separated 27cm from the tip. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

Event Description

It was reported that catheter removal difficulties were encountered and balloon tear occurred. A 3. 0mm x 100mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation. However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder. The guide and the balloon were removed from the patient. No patient complications were reported.

• Brand Name: STERLING¿ SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 6393516
• MDR Text Key: 69559645
• Report Number: 2134265-2017-01699
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2018
• Device Model Number: H74939147301010
• Device Catalogue Number: 39147-30101
• Device Lot Number: 19031834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial