MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135191

Device Problems Break (1069); Material Frayed (1262); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565); Insufficient Information (4580)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, after asepsis and antisepsis with iodides infiltrate with lidocaine without epinephrine, single right femoral puncture was performed and the guide wire, dilators and catheter were passed.When removing the guide wire, there was difficulty in its removal and fragmented guide wire (completely fragmented) was obtained.It was fixed, and when the lumens return was checked, there was no adequate return by one lumen and with difficulty returning in the other.The catheter was not repaired and there was no leak.Iodine solution was used for asepsis and antisepsis of the device.There was no luer adapter issue and the insertion site was treated with iodine solution prior to product solution.The specialist responsible for the procedure requested catheter review by interventional radiology as a vital urgency and in turn passed a new catheter through interventional radiology.There was no reported patient outcome.

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

According to the reporter, after asepsis and antisepsis with iodides infiltrate with lidocaine without epinephrine, single right femoral puncture was performed and the guide wire, dilators and catheter were passed.When removing the guide wire, there was difficulty in its removal and fragmented guide wire (completely fragmented, guide wire broke) was obtained.It was mentioned that the guide wire broke at the proximal end and the retained pieces remained in the patient's body.The catheter was fixed or sutured to guarantee stability of the catheter, and when the lumens return was checked (permeability of the catheter was checked by drawing blood), there was no adequate return by one lumen and with difficulty returning in the other.The catheter was not repaired and there was no leak.Iodine solution was used for asepsis and antisepsis of the device.There was no luer adapter issue and the insertion site was treated with iodine solution prior to product solution.There was no damage to the device's case and packaging.Moderate force was used to pull/remove the product.There was nothing unusual observed on the device prior to use and flushing was not done.There were no other products being utilized with the device and there were no other defects/damages found on the product.There was no problem with the size of the catheter and there was occlusion as only permeability was evidenced by one lumen.The guide wire used was the one included in the kit.Manual removal of the guide wire was performed and only the guide wire was removed (catheter was not removed, as it was fixed and was reviewed by angiography).Doppler echo of neck vessels, femoral vessels, explant and catheter implantation (the specialist responsible for the procedure requested catheter review by interventional radiology as a vital urgency and in turn passed a new catheter through interventional radiology) and removal of foreign body was performed.By using a new catheter, the procedure was completed.There were no other interventions/treatment required as a result of the event.There was no blood loss.The event did not cause or prolong hospitalization of the patient.

Manufacturer Narrative

Additional information: g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, h3, h6 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted a piece of the guidewire detached from the main body and was left in the patient.It was reported that the guide wire broke apart, there was an insufficient flow issue, and the device was occluded.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

Event Description

According to the reporter, after asepsis and antisepsis with iodides infiltrate with lidocaine without epinephrine, single right femoral puncture was performed and the guide wire, dilators and catheter were passed.When removing the guide wire, there was difficulty in its removal and fragmented guide wire (completely fragmented, guide wire broke) was obtained.It was mentioned that the guide wire broke at the proximal end and the retained pieces remained in the patient's body.The catheter was fixed or sutured to guarantee stability of the catheter, and when the lumens return was checked (permeability of the catheter was checked by drawing blood), there was no adequate return by one lumen and with difficulty returning in the other.The catheter was not repaired and there was no leak.Iodine solution was used for asepsis and antisepsis of the device.There was no luer adapter issue and the insertion site was treated with iodine solution prior to product solution.There was no damage to the device's case and packaging.Moderate force was used to pull/remove the product.There was nothing unusual observed on the device prior to use and flushing was not done.There were no other products being utilized with the device and there were no other defects/damages found on the product.There was no problem with the size of the catheter and there was occlusion as only permeability was evidenced by one lumen.The guide wire used was the one included in the kit.Manual removal of the guide wire was performed and only the guide wire was removed (catheter was not removed, as it was fixed and was reviewed by angiography).They had to use doppler echo of neck vessels plus femoral vessels, for the explantation and catheter implantation (the specialist responsible for the procedure requested catheter review by interventional radiology as a vital urgency and in turn passed a new catheter through interventional radiology) and for the removal of foreign body.By using a new catheter, the procedure was completed.There were no other interventions/treatment required as a result of the event.There was no blood loss.The event did not cause or prolong hospitalization of the patient.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11444275
• MDR Text Key: 238655978
• Report Number: 3009211636-2021-00058
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2010600087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention