MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813793009

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during the implantation procedure, the guidewire was introduced into the patient through the puncture needle.The needle was withdrawn and the two dilators were inserted.After dilation, the catheter was inserted through the guidewire.In the removal of the guidewire, it did not move and there was resistance.They had to remove both the catheter and guidewire from the insertion site.After it was removed from the patient, the guidewire was removed from the catheter using force which caused one wire to tear and rupture (but not completely separated).The catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue.They had to perform x-ray as a precaution that all parts were recovered and no fragments were identified.The guidewire used was the one provided/included in the kit.Dry gauze was used as a cleaning agent on the device and the insertion site was treated with chlorhexidine degermante 2% for skin degeneration in jugular prior to product placement.Nothing unusual was observed on the device prior to use and there was no damage to the case and packaging.They had to use a replacement product from another brand to complete the procedure the next day.There was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: only the guide wire was received.The guide wire was coiled and unraveled.The condition in which the device was received precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the coiled and unraveled guide wire may occur when mishandled during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: b5, g4.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, during the implantation procedure, the guidewire was introduced into the patient through the puncture needle.The needle was withdrawn and the two dilators were inserted.After dilation, the catheter was inserted through the guidewire.In the removal of the guidewire, it did not move and there was resistance.They had to remove both the catheter and guidewire from the insertion site.After it was removed from the patient, the guidewire was removed from the catheter using force which caused one wire to tear and rupture (but not completely separated).The catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue.They had to perform x-ray as a precaution that all parts were recovered and no fragments were identified.The guidewire used was the one provided/included in the kit.Dry gauze was used as a cleaning agent on the device and the insertion site was treated with chlorhexidine degermante 2% for skin degeneration in jugular prior to product placement.Nothing unusual was observed on the device prior to use and there was no damage to the case and packaging.They had to use a replacement product from another brand to complete the procedure the next day.There were no patient symptoms or complications associated with this event.There was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or e xtend patient hospitalization.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9331299
• MDR Text Key: 167159882
• Report Number: 3009211636-2019-00244
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1729300127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention