MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939293068030

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.During preparation for a stenting procedure, the physician selected an innova 6 x 80 x 130 stent.The stent deployed outside the patient on the table.The device never entered the patients body.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, middle shaft and the remainder of the device were checked for damage.The outer sheath showed a kink at the nosecone.There was also a kink approximately 43cm from the nosecone on the outer sheath.No additional damage was noticed.The stent was returned inside the device and it was inadvertently partially deployed approximately 8mm from the marker band.Ops engineering opened the handle to inspect for additional damage, no additional damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.During preparation for a stenting procedure, the physician selected an innova 6 x 80 x 130 stent.The stent deployed outside the patient on the table.The device never entered the patients body.No patient complications were reported.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 6619501
• MDR Text Key: 76970018
• Report Number: 2134265-2017-05499
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874010
• UDI-Public: (01)08714729874010(17)20200229(10)20347587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: H74939293068030
• Device Catalogue Number: 39293-06803
• Device Lot Number: 20347587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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