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

Catalog Number SLC2015X

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/01/2022

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 two solarice rx ptca balloon catheters to treat moderately tortuous, moderately calcified lesions in the mid left anterior descending (lad) artery and circumflex (cx) artery. the devices were not inspected before use.Negative prep was performed on the second device (slc2015x), with no issues.The lesion was not pre-dilated.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the first device (slc2012x), but resistance was not encountered when advancing the second device (slc2015x).Excessive force was not used during delivery of either device. it was reported that for the first device (slc2012x), a balloon burst occurred during the first balloon inflation at 14 atm. for the second device (slc2015x), it was reported that a balloon burst occurred during inflation at 12 atm.No patient injury reported.

Manufacturer Narrative

Additional information: 90% stenosis was present in the lesion.A calcified nodule was noted.Negative prep was performed on the first device (slc2012x)prior to use.The devices were being used to pre-dilate the lesion.For the second device used (slc2015x) the burst occurred on the first inflation.The balloons were moved or repositioned while inflated upon encountering some resistance.The current patient status is reported to be stable.Patient weight provided.Product analysis: the device was received for analysis.The device returned with balloon folds expanded.Numerous kinks were evident along the distal shaft and core wire.Blood was visible in the balloon and inflation lumen.The balloon passed negative prep, however upon visual inspection of the device, a longitudinal tear was observed on the balloon material, along 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.

• 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: 15948386
• MDR Text Key: 306065441
• Report Number: 9612164-2022-04654
• 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
• Report Date: 02/02/2023

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: SLC2015X
• Device Lot Number: 224592396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG