MAUDE Adverse Event Report: MEDTRONIC MEXICO CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG13160-0615-1S

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Refer to manufacturer report 2029214-2023-02391 for related device.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

Medtronic received a report that on the first attempt the healthcare provider (hcp) felt friction of the solitaire within the microcatheter during delivery.The vessel was not tortuous.At the distal part of the microcatheter, friction got very high.Friction occurred in the middle and distal portion of the catheter.Hcp decided to replace the microcatheter and took a new phenom 21.The friction was still the same and this time, they attempted to remove the solitaire from the microcatheter.Hcp finished with the solitaire broken inside the microcatheter.When hcp did an angio run, he saw that a foreign body was left in the artery.Hcp thought that it is a piece from the inner liner of the microcatheter.The patient did not have vessel stenosis proximal to the thrombus site.The pushwire was not torqued during the procedure.There were 0 passes made using the stent.The microcatheter tip did not cover the stent proximal marker during retrieval.The stent was removed from the patient.The physician did not attempt to detach the stent.The pushwire break/separation was in the distal section of the pushwire.All segments of the pushwire were removed from the patient as it was broken outside of the patient's body when trying to remove the solitaire from the microcatheter.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of bazilar ischemic stroke.Modified rankin scale (mrs) score baseline was 0, procedure 0.Tici score post procedure was 2c.There were 0 passes with the device.Vessel tortuosity was normal.Stroke onset to reperfusion time was 5.5 hours.The access vessel was the right femoral artery.Refer to manufacturer report 2029214-2023-02391 for related device.

Manufacturer Narrative

B5.Updated with additional information received.Associated with mdr #: 2029214-2023-02391, 2029214-2023-02393.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 email received confirmed two phenom microcatheters were involved.It was unknown which catheter, if either, resulted in the observed possible foreign body in the patient artery.

Manufacturer Narrative

Product analysis: as found condition: the solitaire x revascularization device and phenom 21 catheter were returned for analysis within a shipping box and a sealed pouch.Damage location details: the solitaire x pusher was found extending out from within the phenom 21 catheter hub for 35.0cm.The phenom 21 catheter hub was found to be in good condition.No bends or kinks were found with the phenom 21 catheter body.The phenom 21 catheter distal tip was found to be in good condition.The solitaire x revascularization device was removed from within the phenom 21 catheter.Testing/analysis: the phenom 21 catheter was flushed, water exited from the distal tip.An in-house 0.021¿ mandrel was inserted through the phenom 21 catheter without issue.The separated solitaire x pusher was sent out for sem failure analysis.Per the sem report, the broken end failed via ductile overload.Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance during delivery¿ and ¿pushwire break/separation¿ reports were confirmed.Damage to the solitaire x pusher (break/separation/bent/marker coil pulled back) can occur if the device is advanced/retrieved against resistance.Resistance during delivery can occur due to the use of an incompatible catheter, catheter damage, patient vessel tortuosity, or not maintaining continuous flush.The use of an incompatible catheter, catheter damage, and patient vessel tortuosity were ruled out as potential causes.However, not maintaining a continuous flush could not be ruled out as a potential cause.As indicated in the solitaire x instructions for use (ifu), ¿all solitaire¿ x revascularization devices should be introduced through a microcatheter with an inside diameter of 0.021-0.027 inches.¿ the phenom 21 catheter has a labeled inner diameter of 0.021¿.Therefore, the phenom 21 catheter is compatible with the solitaire x revascularization device.In addition, no defect or damages were found with the returned phenom 21 catheter that would have contributed to the reported resistance.The patient¿s vessel tortuosity was normal.However, information regarding the use of a continuous flush was not reported.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: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18343886
• MDR Text Key: 330715372
• Report Number: 2029214-2023-02392
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 226747732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG