MAUDE Adverse Event Report: MEDTRONIC MEXICO SOLARICE RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Catalog Number SLC2020X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 06/27/2023

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 one solarice rx ptca balloon catheter to treat a moderately tortuous, moderately calcified lesion in the mid left anterior descending (lad) artery.The device was not inspected.Negative prep was performed with no issues noted.The lesion was not pre-dilated.Excessive force was not used during delivery.It was reported that a balloon burst, leak or catheter leak occurred during balloon inflation.It was detailed that the balloon burst occurred at 12 atm.The patient is alive with no injury.Please note that this device solarice rx is not marketed in the united states; however, it is similar to the united states marketed device euphora rx.This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

Manufacturer Narrative

Additional information: the device was inspected before use.The solarice balloon was being used to pre-dilate the lesion.Resistance was not noted while advancing the device to the lesion.It was later confirmed that it was a catheter leak which occurred.No inflation had been performed prior to the issue occurring and the catheter leak occurred on the first inflation.The device was not moved or repositioned while inflated.The device was not inflated due to the leakage.Product analysis: the device was returned for analysis.Kinks were evident on the hypo-tube and transition shaft.The device returned with balloon folds partially expanded.The balloon failed negative prep.Deformation was evident to the distal tip.On pressurization of the device, liquid was observed exiting the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, two short longitudinal tears were observed on the balloon working length.The balloon material was jagged and uneven at the tear site.No other damage evident to the remainder of the 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.

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.

• Brand Name: SOLARICE RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17290860
• MDR Text Key: 319399166
• Report Number: 9612164-2023-03088
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2023

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 Catalogue Number: SLC2020X
• Device Lot Number: 224540795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/18/2023; 08/06/2023
• Supplement Dates FDA Received: 07/24/2023; 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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