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

Catalog Number	SPL12510X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7513478
• Report Number: 9612164-2018-01073
• Device Sequence Number: 1225216
• Product Code: LOX
• UDI-Device Identifier: 00643169271753
• UDI-Public: 00643169271753
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Catalogue Number: SPL12510X
• Device Lot Number: 213509448
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1