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

Model Number H965SCH647140

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported that catheter removal difficulty occurred.The target lesion was located in the carotid artery.After a 6fr introducer sheath was advanced, a 10.0-37 carotid wallstent was selected for use but has difficulty advancing through the sheath.It was noted that the catheter got stuck up at the distal part of the sheath.The catheter could not be retrieved nor advanced further.The physician pulled out the entire system from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the introducer sheath used during the procedure was not returned for analysis.The stent was partially deployed by 2mm upon return.As a result the catheter could not be inserted through a 6fr introducer sheath.The remainder of the device was inspected and no issues were noted with its profile.The remainder of the stent was deployed; however during deployment the proximal outer was damaged.Bunching occurred 25mm distal from the clear shrink tubing and damage occurred on the proximal outer 55mm distal from the clear shrink tubing.As a result, the rest of the stent was manually deployed by pulling back on the tip while gripping the outer.No issues were noted with the profile of the stent.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: "never advance a partially deployed carotid wallstent endoprosthesis".(b)(4).

Event Description

It was reported that catheter removal difficulty occurred.The target lesion was located in the carotid artery.After a 6fr introducer sheath was advanced, a 10.0-37 carotid wallstent was selected for use but has difficulty advancing through the sheath.It was noted that the catheter got stuck up at the distal part of the sheath.The catheter could not be retrieved nor advanced further.The physician pulled out the entire system from the patients body and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5000647
• MDR Text Key: 22889296
• Report Number: 2134265-2015-05659
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/15/2015

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: 09/29/2017
• Device Model Number: H965SCH647140
• Device Catalogue Number: SCH-64714
• Device Lot Number: 16856951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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
• Patient Age: 38 YR
• Patient Weight: 59