MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number SP-101

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a venaseal kit during treatment of the patient¿s small saphenous vein (ssv).Ifu was followed.It is reported an 0.035 guidewire was inserted into the vessel and changed for a 0.025 non-medtronic guidewire as the handling was poor.The 0.025 guidewire was advanced and the introducer with a dilator in the kit was inserted.When attempting to remove the guidewire and dilator resistance was encountered and they could not be removed.Force was applied to remove, and the introducer is reported to have broken inside the patient's vessel.The guidewire and introducer with dilator were removed in tandem without intervention.All pieces of the device were accounted for on removal.The cause of the break might be the short sheath (7fr), but the details are unknown.A replacement venaseal kit was opened, and the procedure was completed.No patient injury reported.

Manufacturer Narrative

Product analysis #(b)(4):returned device: introducer and guidewire turned in a double biohazard bag.Pe704216855 was documented on outer bag.The lot number was verified on the product (b)(6) and confirmed as 60885 which is consistent with the reported lot number.No cines or images of the procedure were included.Device was decontaminated with a cidex opa solution and a tergazyme soak visual inspection: bunching and damage was noted on the device (photo 1,2,3) damage was noted to the tip (photo 6) a hole was noted at the hub (photo 7) and on the dilator where the bunching was (photo 8) a non medtronic guidewire was also returned damage was noted to the guide wire (photo 4- 5) conclusion: the reported difficulties removing the introducer and guidewire was confirmed.However, the reported impaired functionality of the guidewire and damaged to the dilator could not be performed as both components were not returned for analysis.Multiple kinks, bunching and holes were noted on the device.No detachment was noted to the device.The most likely cause is handling/procedural related.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11357413
• MDR Text Key: 232791182
• Report Number: 9612164-2021-00721
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: 09/29/2022
• Device Catalogue Number: SP-101
• Device Lot Number: 60885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Manufacturer Received: 02/06/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1