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

Catalog Number SPL25020X

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Intimal Dissection (1333); Fever (1858); Chest Tightness/Pressure (2463)

Event Date 03/19/2019

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 a sprinter legend rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion exhibiting 80% stenosis located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that balloon deflation difficulties were experienced.The device was slow to deflate at the lesion site and could not be removed through the catheter.Repeated attempts were made to remove the device, resulting in a slight tear in the inner wall of the vessel.It was reported that the heartbeat and blood pressure of the patient were noted to be abnormal during the procedure and it is indicated that the patient felt unwell.After the procedure it was reported that the patient had a fever which resolved after two days.The patient is reported to be alive with no further injury.

Manufacturer Narrative

Additional information:no abnormal blood pressure noted.It is stated that difficulties were noted when removing the protective sheath.No difficulties were noted removing the packaging stylette.No difficulties noted during inflation.The deflation difficulties were encountered after the first inflation.The deflation time was at least 5 minutes.Various methods were used to deflate the balloon including pumping with a syringe.Finally, when the balloon was filled with contrast slightly less, the catheter was pulled out together with the guiding catheter, and the balloon was still filled with contrast after being pulled out.The patient had chest tightness and chest pain.1:1 ratio contrast / saline was used.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: the balloon returned fully deflated.There was no deformation to the balloon material.Stretching was evident to the material at the balloon bond causing a narrowing of the inflation lumen material.It was not possible to inflate the device to perform deflation testing due to the stretching on the material at the balloon bond.There was slight deformation to the distal shaft and inner member.There was no deformation to the distal tip.The sheath and stylette were not returned with the device.Image review summary: an image of the complaint device was received for analysis.The image shows the luer of the device, the balloon and a portion of the hypotube and distal shaft.There is no deformation to the device visible in the image.The lot number on the luer matches what was reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND 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: 8455017
• MDR Text Key: 139955515
• Report Number: 9612164-2019-01053
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• 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,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: SPL25020X
• Device Lot Number: 216420172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/27/2019; 06/11/2019
• Supplement Dates FDA Received: 04/26/2019; 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 57