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

Catalog Number SPL12510X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A sprinter legend balloon catheter was used to pre-dilate a non-tortuous, non-calcified lesion in the mid om.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop/tray.The device was inspected with no issues.(b)(6) prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed st ent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It is reported that as the physician inflated the balloon they noticed an aneurysm had developed proximal to the lesion.It is unknown if the balloon was the cause.The patient is reported as being alive without injury.

Manufacturer Narrative

Image review: cine image provided by the account, capturing the inflation of an unknown device.There appears to be a ¿bulge¿ proximal to the inflated balloon.Contrast is not visible being injected into the vessel from the still cine image provided therefore a vessel aneurysm cannot be confirmed.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: 7513478
• MDR Text Key: 108226519
• Report Number: 9612164-2018-01073
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169271753
• UDI-Public: 00643169271753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Catalogue Number: SPL12510X
• Device Lot Number: 213509448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Date Device Manufactured: 06/19/2017
• 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