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

Catalog Number UNK-CV-GWY-SOL

Device Problems Deflation Problem (1149); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure an attempt was made to use one solarice rx ptca balloon catheter to treat a lesion.The device was inspected with no issues noted.Negative prep was not performed.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that balloon deflation difficulties were encountered, the device was slow to deflate at the lesion site.It was informed that it took longer than normal to deflate the balloon and a lot of effort was needed to deflate the balloon.It was reported that the balloon failed to deflate and was reported to look damaged "invaginated".One part of the balloon was covering another part of the balloon.The device was kinked and re-straightened during use.No patient injury was reported.It was reported that after the event, the balloon was cut, so just the balloon portion remains.

Manufacturer Narrative

Evaluation summary: the distal portion of the device returned for analysis.The balloon appeared to have moved distally over the distal tip.The distal portion of the balloon appeared to have folded in on itself.The proximal markerband was positioned in the proximal balloon bond.The balloon bond and inner member were severely stretched.There were no kinks evident to the distal shaft.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: 8221329
• MDR Text Key: 132203074
• Report Number: 9612164-2019-00067
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: UNK-CV-GWY-SOL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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