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

Model Number SLC2520X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A solarice rx ptca balloon catheter was used during a procedure to treat a severely calcified lesion.It was reported that the balloon burst at 14atm.There is no patient injury reported.

Manufacturer Narrative

Additional information: the device was being used to treat a mildly tortuous, moderately calcified lesion with 75% stenosis in the mid right coronary artery (rca).The device was inspected before use with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated with the same balloon at 8-10 atm.No resistance was noted when advancing the device to the lesion.Excessive force was not used.The device did not pass through a previously deployed stent.The device was not moved or re-positioned in the lesion while inflated.It was stated that the balloon was first inflated to 8-10 atm and was deflated.The balloon was then advanced further in the lesion and a second inflation was performed.There was a sudden drop in pressure noted on the inflation device the balloon burst occurred on second inflation at 14 atm.The patient was reported to be alive with no injury.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLARICE RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10127251
• MDR Text Key: 194306501
• Report Number: 9612164-2020-02119
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: SLC2520X
• Device Catalogue Number: SLC2520X
• Device Lot Number: 218795385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2020
• Date Device Manufactured: 10/29/2019
• 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: 71 YR
• Patient Weight: 65