MAUDE Adverse Event Report: LEMAITRE VASCULAR INC. 1.5 HYDRO LEMAITRE VALVULOTOME

Catalog Number 1009-00

Device Problems Material Separation (1562); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

We have not yet received the device, so we cannot conclusively determine the root cause of the defect.On 12/1/2016, we received some unopened boxes of valvulotome but the complaint device was missing in the box.When we contacted the hospital regarding the missing device via phone, they did not know where it went.According to the sr.Rn, the patient did not experience any further complications due to the change in the planned procedure, and he was discharged from the hospital to his long-term care facility as per his original care plan.We are aware of this issue with this lot and it was already part of our ongoing recall for this issue.We had informed the hospital regarding the defect with this lot through mail.We have received the form back from the hospital on 8/18/2016 and on 10/7/2016 stating they do not have any devices from this lot or any other lots listed in the recall.However, after the incident and during the follow up with the hospital, we found that the hospital had devices from the recalled lot that were kept in offices instead in their warehouse.They returned the devices on 12/01/2016.Device not received from hospital.

Event Description

Valvulotome blades did not return to sheath when it was activated and the blades got stuck to the walls of the vessel.The doctor passed the valvulotome into the lumen of the vein to use it as a bypass graft.The tip was deployed and the device was retracted distally through into the lumen of the vessel when he observed the device was no longer moving with gentle backward tension.After some time of increased backward tension, the surgeon stated the device might have separated, leaving the thin black filament between the sheath and the tip of the valvulotome.The vessel was then rendered useless for bypass surgery as part of the process of retrieving the tip.The patient was implanted with a synthetic graft rather than native tissue as planned.

• Brand Name: 1.5 HYDRO LEMAITRE VALVULOTOME
• Type of Device: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 6139310
• MDR Text Key: 61548087
• Report Number: 1220948-2016-00024
• Device Sequence Number: 1
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: 00840663106653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1071VA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79