MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC INTRODUCER; INTRODUCER, CATHETER

Model Number MDT-INTRODUCER

Device Problem Use of Device Problem (1670)

Patient Problems Hemothorax (1896); Great Vessel Perforation (2152); Vascular Dissection (3160)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, during the implantable pulse generator (ipg) changeout procedure, the patient exhibited superior vena cava (svc) stenosis/narrowing and experienced hemothorax, confirmed with contrast, and svc perforation and dissection, confirmed on angiography, with inadvertent atrial cauterization.It was also reported the implantable pulse generator (ipg) exhibited a telemetry problem, when tested intra-operatively, post use of cautery.The ipg was explanted.It was also reported that the right atrial (ra) lead exhibited high thresholds and loss of capture, when tested intra-operatively, post use of cautery.On an attempt to replace the ra lead, the sheath could not be advanced past the svc narrowing, bending the existing ra lead and rv lead, but subsequently passed using a dilator.The tip came out of the sheath and was used without pulling it back in.The ra lead was capped and replaced.The rv lead was capped for potential future use.It was further reported that the replacement right atrial (ra) lead did not initially advance at the svc narrowing, at the time of perforation, and stress was applied to push it through the narrowed area.The patient had a thoracotomy and the perforation site was sutured closed. the replacement ra lead was attempted/not used and replaced.This second replacement ra lead was subsequently, capped for potential future use. the patient had an extended hospitalization period as a result of t his event.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that no malfunction was noted with the introducer sheath.The ipg was replaced.

Manufacturer Narrative

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.

Manufacturer Narrative

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: MEDTRONIC INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12643911
• MDR Text Key: 276847790
• Report Number: 2182208-2021-04120
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-INTRODUCER
• Device Catalogue Number: MDT-INTRODUCER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG