MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

Catalog Number IAV09008008P

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2022

Event Type  Injury  

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.

Event Description

An inpact av access drug eluting balloon was used to treat a proximal, mid, distal fibrous lesion with chronic total occlusion in the femoral av access graft of a patient.Little tortuosity and calcification were present.The device was prepped as per the ifu with no issues identified.A non-medtronic guidewire (storq 035) and inflation device (boston) was used.No issues noted when removing the device from the hoop/tray.The balloon was used to deliver drugs on removal balloon fractured coming through sheath.It was reported the balloon fractured on removal through the sheath.The fractured items were removed with forceps and case was complete.The device did not pass through a previously deployed stent, resistance was not encountered when advancing the device, excessive force was not used.No further patient injury reported for this event.

Manufacturer Narrative

Product analysis device decontaminated with cidex opa solution soak and tergazyme soak pending further device testing to support the final product analysis findings.The device returned with the balloon material detached at 4.6cm proximal to the distal tip, with the balloon material being slightly jagged and uneven.The detached part of the balloon had a tear along the length of the balloon beginning 0.5cm proximal from the distal tip and ending at the detachment site.The inner member detached 1.5cm proximal to the distal tip, with the material at this site being jagged and uneven.The remaining part of the inner member was not present in the part of the balloon still attached to the catheter and was not returned with the device, with this detaching at the proximal balloon bond.The marker band was loose in the balloon material still attached to the catheter.The balloon folds were open.A tactile test did not detect any kinks or abnormalities along the length of the catheter.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: IN.PACT AV ACCESS
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15851275
• MDR Text Key: 304174314
• Report Number: 9612164-2022-04379
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: IAV09008008P
• Device Lot Number: 0010287174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 56 KG