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

Catalog Number SLC3030X

Device Problems Deflation Problem (1149); Fracture (1260); Difficult to Open or Remove Packaging Material (2922)

Patient Problems Intimal Dissection (1333); Hematoma (1884)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use one solarice rx ptca balloon catheter to treat a mildly tortuous and calcified lesion in the rca with 50% stenosis.The device was inspected with issues noted, the stylet was hard to remove.Negative prep was not performed.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was not encountered and excessive force was not used during delivery.It was reported that balloon deflation difficulties occurred, the device would not deflate at the lesion site.The balloon was withdrawn with dissection hematomas of the arteries.The device cracked at the introducer.

Manufacturer Narrative

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

Manufacturer Narrative

The pink tip section of the catheter was pushed up onto the loop of the stylette when the catheter was removed from the hoop.The loop of the stylette was not pushed down into the slip in the pink sheath that was covering the balloon.The balloon was inflated twice.There were no difficulties noted during inflation at 8 atm.The balloon was fully deflated in between inflations.The device would not deflate at the lesion site after it was inflated to 12 atm.The device was pulled back to the introducer in an attempt to deflate the balloon.The balloon was burst to deflate it so that it could be removed from the patient.It was the only way to deflate the balloon.The concentration of contrast / saline was contrast 50% _ 50% nacl.The guide catheter used was a 6f launcher (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: device returned loaded in a guide catheter.The sheath and stylette did not return for analysis.The strain relief and hypotube were bent.Negative prep was performed and there was no leak evident.The distal section of the balloon had been advanced through the guide catheter.The distal tip appeared to have been pulled back into the balloon, the tip material appeared stretched.The hypotube was cut proximal of the guide catheter and the remaining section of the device was removed from the guide catheter.The balloon bond was necked and stretched.The markerbands were not in the correct position due to stretching of the inner member.The balloon was inflated to inspect for leaks or burst.The balloon maintained pressure.The balloon deflated in 27 seconds with spec being =20 seconds.Additional information: the dissections were treated with 2 resolute integrity stents.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.

• 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: 8854317
• MDR Text Key: 153066614
• Report Number: 9612164-2019-03196
• 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,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Catalogue Number: SLC3030X
• Device Lot Number: 217427708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• 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): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 70