MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. VASCUTAPE RADIOPAQUE TAPE

Catalog Number	1108-20
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Radiation Burn (1755); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the vascutape was not removed from the patient's leg for two weeks after the procedure.The vascutape product is not intended to be placed on the patient for more than 24 hours.The patient underwent an mri while the product was still on the patient.As a result, the markings of the tape were burned onto the patient's leg during the mri and excoriated down toward the ankle causing peeling and redness.The patient required treatment for wound care and antibiotics to prevent infection.It was determined that this issue is due to a user error.The vascutape product is not intended to be left on the patient for more than 24 hours and is not suitable for use in an mri procedure.When the product was left on the patient, it caused a reaction when the patient went through the mri procedure resulting in the event.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.
Event or Problem Description
Tape was not removed from patient's leg for two weeks after procedure.Patient underwent mri with tape inadvertantly on his leg, resulting in pain and redness, as well as burn of the tape markings as an imprint on the patient's leg after tape was finally removed.Patient had angio procedure in ir suite on (b)(6) 2024, followed by lysis case the following day; issue arose when mri conducted 2 weeks later on (b)(6) 2024 with tape still on.Patient finally removed tape from his leg (b)(6) 2024, several days after mri, and observed the redness and markings.Tape measurement markings were burned into patient's leg during mri; excoriated down towards the ankle, peeling and red.Patient is being treated with wound care and antibiotics and was discharted but followed up with by ir suite on (b)(6) 2024.

• Brand Name: VASCUTAPE RADIOPAQUE TAPE
• Common Device Name: TAPE
• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 18907870
• Report Number: 1220948-2024-00063
• Device Sequence Number: 15329768
• Product Code: KFX
• UDI-Device Identifier: 00840663100385
• UDI-Public: (01)00840663100385
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K932184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1108-20
• Device Lot Number: GTF1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown