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

Catalog Number SLC2515X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Difficult to Open or Remove Packaging Material (2922)

Patient Problems Injury (2348); Vascular Dissection (3160)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

The solarice device is considered to be the same as euphora with the exception of a different brand name and minor differences in the labeling.If information is provided in the future, a supplemental report will be issued.

Event Description

A solarice rx ptca balloon catheter was used to treat a moderately tortuous, mildly calcified lesion exhibiting 70% stenosis in the distal saphenous vein graft (svg).The device was inspected with issues noted.The lesion was pre dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that balloon deflation difficulties were encountered at the lesion site.The balloon was removed inflated and removal difficulties were encountered.It was reported that a dissection was caused by removing the not deflated balloon.The dissection was treated using a resolute integrity device.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis summary: a stopcock was attached to the luer of the device.The stylette was not loaded in the device, it was returned separate to the device.Deformation was evident to the distal tip.The balloon folds were expanded.The balloon was partially inflated.The proximal balloon bond was necked and stretched.Blood was visible on the balloon.It was not possible to inflate the balloon to perform deflation testing due to the condition of the balloon bond.A residue that was red in colour was visible on the stylette 43mm proximal to the hook of the stylette.There was no other damage evident to the remainder of the device.Additional information: light resistance was noted when removing the stylette.A little bit of force was required to remove the sheath and stylet.The balloon was inflated once to 12 bar.A non-medtronic guidewire was used.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: 8964226
• MDR Text Key: 156568512
• Report Number: 9612164-2019-03761
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Catalogue Number: SLC2515X
• Device Lot Number: 217693884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 9612164-09-12-2019-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 90