MAUDE Adverse Event Report: MEDTRONIC, INC PWP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 150075

Device Problem Deflation Problem (1149)

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

Event Date 10/17/2022

Event Type  malfunction  

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 attempt was made to use two pulmonary wedge press (pwp) catheters in a non calcified, non tortuous femoral vein.There was no damage noted to the packaging of the devices.The devices were removed from the packaging and prepped per ifu with no issues.The devices were inspected with no issues.It was reported that the first pwp catheter would not deflate.The device was placed at the femoral vein and the balloon would not deflate when attempted to.The catheter was removed and the second pwp catheter was then attempted to be used.However, the second device would not inflate outside of the body.This device never went into the patient's body.A third pwp catheter was used and worked properly.There was no resistance encountered when advancing the first device, and excessive force was not used during delivery.The patient is alive with no injury.

Manufacturer Narrative

Additional information: for the first device, there were no issues noted during inflation of the balloon.Two inflations were applied when the deflation issue occurred.The device was moved/ repositioned while inflated.A slight pressure with very little force was applied during inflation.Air inflation medium was used.The device was removed from the patient by slight back pressure through the sheath with no difficulties experienced.No intervention was required to remove the device from the patient.An air inflation medium was used when attempting to inflate the second pwp balloon.The syringe provided with the pwp devices was used with the pwp devices.The syringe was connected directly to the inflation leg.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.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

Product analysis: two pulmonary wedge press (pwp) catheters were received for analysis.The first device returned with syringe attached, positioned at approx.1.5cc and stopcock was in open position.No damage noted to the balloon.With the syringe plunger positioned at approx.1.5cc the balloon was inflated, and stopcock closed.The balloon inflated and held pressure.During the first deflation attempt the stopcock was opened open but balloon remained partially inflated with the syringe plunger retracting to approx.1.1cc.During a second deflation attempt the stopcock was opened open but balloon again remained partially inflated with the syringe plunger retracting to approx.1.1cc.The syringe was detached from the device and the balloon was then observed fully deflating.While detached from the device the syringe plunger was advanced and retracted and there was no issue noted.There was no observable damage to the device or syringe.Ten deflation tests were performed with an in-house syringe and the balloon deflated each time with no issues noted.The device was tested ten times with the returned syringe.The balloon successfully deflated once and failed to fully deflate nine times.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

Additional information/syringe review the returned syringes were shipped to the manufacturer for analysis.The samples were visually and physically evaluated per specifications.Syringe suction and pressure tests were performed with passing results.No product deviation was noted.Based on the evaluation results, the product (syringes) met internal specifications.Annex d code 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: PWP CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15822980
• MDR Text Key: 307689224
• Report Number: 1220452-2022-00087
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00613994733658
• UDI-Public: 00613994733658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884065
• 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,Followup,Followup
• Report Date: 08/17/2023

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: 05/10/2024
• Device Model Number: 150075
• Device Catalogue Number: 150075
• Device Lot Number: 0011211207
• 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: 11/18/2022
• Supplement Dates Manufacturer Received: 12/02/2022; 12/22/2022; 07/24/2023
• Supplement Dates FDA Received: 12/19/2022; 01/20/2023; 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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 Age: 61 YR
• Patient Sex: Female