MAUDE Adverse Event Report: MALLINCKRODT MEDICAL CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Model Number 41060-01

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the rn was removing a mcnamara catheter from the sheath and did not notice that it broke and part of it stayed in the sheath and the patient.

Event Description

Additional information received reported the catheter broke off when the nurse pulled it out, the remaining part that broke off in the patient was entrapped in the sheath.

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

Additional information received reported the cragg mcnamara was placed in the cath lab the previous day.The next morning an icu nurse was told to remove the cragg mcnamara.Per the nurse, no resistance was felt removing the catheter, the nurse thought the whole catheter was removed through the 8fr sheath.The sheath was left in place for the follow up angio later that day.Once the sheath was under fluoro, the rest of the cragg mcnamara was seen in the sheath.The physician was able to put a wire into the sheath and through the cragg mcnamara.Both were removed and a new 8 fr sheath was placed.No injury was noted and the rest of the procedure was performed.

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: CRAGG-MCNAMARA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14306900
• MDR Text Key: 290923967
• Report Number: 8020889-2022-00072
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00763000272524
• UDI-Public: 00763000272524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2022

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 Model Number: 41060-01
• Device Catalogue Number: 41060-01
• Device Lot Number: 202112005E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 04/27/2022; 05/26/2022; 06/21/2022
• Supplement Dates FDA Received: 05/26/2022; 06/21/2022; 07/13/2022
• Date Device Manufactured: 12/20/2021
• 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): Other
• Patient Sex: Male
• Patient Weight: 112 KG