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

Catalog Number	SPL12510X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to use a sprinter legend balloon catheter to treat a moderately tortuous, severely calcified lesion with 95% stenosis in the mid lad.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was not inspected and negative prep was performed with no issues.The lesion was not pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used during delivery.There were no abnormalities in anatomy.It is reported that a balloon burst or leak occurred on the first inflation after 12 atm of pressure had been applied.The balloon burst while being expanded in the patient with heavy calcium.The device was being used to pre-dilate the lesion.The device was not moved or re-positioned prior to the burst.The device was replaced by another manufacturers product.No patient injury is reported.
Additional Manufacturer Narrative
The physician thought that a pin hole occurred while he was inflating in a heavy calcified lesion.There was a gradual drop in pressure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7002961
• Report Number: 9612164-2017-01542
• Device Sequence Number: 10892416
• Product Code: LOX
• UDI-Device Identifier: 00643169271753
• UDI-Public: 00643169271753
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2020
• Device Catalogue Number: SPL12510X
• Device Lot Number: 212917792
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/03/2017; 12/20/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 12/01/2017; 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1