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

Model Number H74939293084030

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the stent delivery system (sds) became stuck on the wire.An 8 x 40 x 130 innova¿ stent was selected for use in the superficial femoral artery (sfa).The stent was deployed and implanted successfully.However, after the stent was deployed, the sds became stuck on the non-bsc guidewire and the physician lost access.The guidewire and sds were removed together.There were no patient complications reported and the patient was fine post procedure.

Manufacturer Narrative

Device evaluated by mfr: there was a kink on the mid-shaft located 4cm from the proximal end of the markerband.There was buckling at the nosecone.There was buckling along the catheter shaft in multiple areas located at 13cm and 36cm from the nosecone.There was a kink 1.5cm from the nosecone.There was a.035 guidewire that was stuck in the device when returned.The guidewire was protruding from the distal tip 27cm.The guidewire was protruding from the proximal end of the device 72.5cm.The stent was not returned.The guidewire was removed with some degree of difficulty by flushing the device with fluid and pulling the wire free.The handle was inspected for internal damage and no damage was noticed.The buckling on the outer-sheath is consistent with guidewire sticking issues due to the sheath constricting down on the wire.The kink in the mid-shaft may also have contributed to the guidewire sticking issue.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the stent delivery system (sds) became stuck on the wire.An 8 x 40 x 130 innova stent was selected for use in the superficial femoral artery (sfa).The stent was deployed and implanted successfully.However, after the stent was deployed, the sds became stuck on the non-bsc guidewire and the physician lost access.The guidewire and sds were removed together.There were no patient complications reported and the patient was fine post procedure.

• 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: 7739777
• MDR Text Key: 115770846
• Report Number: 2134265-2018-06719
• Device Sequence Number: 1
• Product Code: NIP
• 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: 07/09/2018

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: 05/09/2021
• Device Model Number: H74939293084030
• Device Catalogue Number: 39293-08403
• Device Lot Number: 22100361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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