MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT?; STENT, CAROTID

Model Number H7493915010240

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in the moderately calcified and severely tortuous left internal iliac artery.After predilation was performed with a 3x2mm sterling balloon catheter, a 10.0-24 carotid wallstent¿ was advanced to treat the lesion and upon advancing, it was noted that the non bsc guide catheter was dislodged from the vessel.The physician then set up the device again, however, the stent failed to cross the lesion.The procedure was not completed as same device was unavailable.No patient complications were reported and the patient's status was good.However, returned device analysis revealed stent was partially deployed.

Manufacturer Narrative

Age at time of event:18 years or older.(b)(4).Device evaluated by mfr: a visual examination of the returned device found that the stent was partially deployed by 1mm.It was noted that the shaft was kinked at 321mm proximal to the tip and that the outer sheath was torn for 7mm proximally from the monorail exit.No other issues were noted with the profile of the device.Measurement of the outer diameter (od) of the device were within specification.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).

• Brand Name: CAROTID WALLSTENT?
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4010630
• MDR Text Key: 4958239
• Report Number: 2134265-2014-04914
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2017
• Device Model Number: H7493915010240
• Device Catalogue Number: 39150-1024
• Device Lot Number: 16679262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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
• Treatment: INTRODUCER SHEATH: DESTINATION/6FR-90CM/TERUMO; GUIDE CATHETER: DESTINATION; BALLOON CATHETER: STERLING/3X2/BSJ