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

Model Number H965SCH647070

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

It was reported that premature deployment of stent occurred.A 8.0-21 carotid wallstent¿ stent was introduced into the y connector with an unspecified 6f system.The physician noticed that the stent shaft was a little curve than the normal.However, the stent suddenly deployed in the y connector.The whole system was removed and the procedure was completed using another stent.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: 18 years or older.(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).

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device found that the stent had been deployed from the device and was not returned.The outer sheath was closed to the tip of the delivery device and no issues were noted with the profile of the delivery device.During analysis it was possible to insert the device through a 5fr introducer sheath without issue.Measurement of the outer diameter (od) of the device at various locations found that all measurements were within the system profile specification.During analysis it was not possible to retract the outer sheath due to a restriction met, possibly due to the dried blood inside the shaft.The shaft was dissected and the inner was withdrawn from the outer sheath.No issues were noted with the profile of the stent holder or the stent sleeve.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that premature deployment of stent occurred.A 8.0-21 carotid wallstent stent was introduced into the y connector with an unspecified 6f system.The physician noticed that the stent shaft was a little curve than the normal.However, the stent suddenly deployed in the y connector.The whole system was removed and the procedure was completed using another stent.No patient complications were reported and the patient's status was good.

• 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: 3868924
• MDR Text Key: 21447337
• Report Number: 2134265-2014-03272
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Followup
• Report Date: 05/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2016
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 15856979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1