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

Model Number SPL12510X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/21/2017

Event Type  Injury  

Event Description

It was reported that the physician was attempting to use a sprinter legend rx balloon to treat a severely calcified and mildly tortuous lad lesion exhibiting 90% stenosis.It was reported that the balloon tore / broke during removal of the balloon.The detached portion of the device remained in the patient's body.An attempt was made to remove the detached portion but attempt was unsuccessful.The patient was then transferred to the cardiac surgery department where removal of the fragment was planned by thoracotomy.

Manufacturer Narrative

Additional information: no issues were noted during device inspection prior to use.The balloon tore / broke in the coronary artery during removal of the balloon.Rather strong resistance was noted during withdrawal.The device was used in a normal manner.Deflation was confirmed before attempting to remove the device from the patient.The thoracotomy occurred on the same day.The detached portion was discarded.The sales rep reported that the patient was transferred to bypass surgery, but further information is not obtained regarding patient outcome.Evaluation summary: blood residue was visible through the distal shaft.Numerous kinks were evident on the hypotube.The device returned with a detachment on the distal shaft; 34cm distal to the guidewire entry port.The lumen material was badly stretched, and proximal side of the detachment site was jagged and uneven.Distal side of detachment side was not returned for analysis.Kinks were evident throughout the distal shaft; 4-10cm proximal to the detachment site.Cine image review two still cine images were provided by the account capturing the left coronary vessels.A guidewire is visible in the vessel.There appears to be a single radiopaque marker visible on the guidewire; this is possibly the detached portion of material from the sprinter legend device.However, this cannot be confirmed.The root cause of the material detachment could not be determined from the still images.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: 6716855
• MDR Text Key: 80142139
• Report Number: 9612164-2017-00904
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

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 Expiration Date: 05/27/2018
• Device Model Number: SPL12510X
• Device Catalogue Number: SPL12510X
• Device Lot Number: 209650749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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