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

Model Number H74939181056030

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: 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.The pull rack was in the start position.The wheel lock was intact.The stent was returned inside the device, but partially deployed approximately.8mm from the markerband.The wheel lock was returned on the device.The wheel lock was removed from the device and the thumbwheel was rotated to see if the stent would deploy any further.The stent did deploy further which confirms no damage to the internal components was present.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

During preparation, a 5x60x130 innova¿ was observed to be partially deployed within the package.The procedure was completed with another same device.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: 6878245
• MDR Text Key: 87644561
• Report Number: 2134265-2017-09164
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2017

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: 05/18/2020
• Device Model Number: H74939181056030
• Device Catalogue Number: 39181-05603
• Device Lot Number: 20646433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2017
• 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