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

Catalog Number	SPL25012X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One sprinter legend ptca balloon catheter was attempted to be used to pre-dilate a lesion.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop/tray.The device was not inspected.Negative prep was performed with no issues.No difficulties noted when removing the protective sheath or stylette from the device.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon was inflated to nominal pressure and was unable to deflate at the lesion site after the first inflation.The device had not been moved or re-positioned prior to deflation difficulties.A 50/50 contrast to saline solution was used.The entire delivery system was then pulled out, with the wire, from the vessel.It was informed that the large artery allowed for the successful removal of the device with no issues.A non-medtronic balloon catheter was then used to pre-dilate and stent was successfully deployed at the lesion site.No patient injury is reported.
Additional Manufacturer Narrative
Device evaluation: device returned with guidewire loaded.Guide catheter was received with device.It was not possible to remove the guide wire from the device.The balloon returned partially inflated with residue present inside the balloon.The proximal balloon bond was stretched.It was not possible to inflate the balloon due to the stretched proximal balloon bond, therefore deflation testing could not be carried out.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: 7641335
• Report Number: 9612164-2018-01555
• Device Sequence Number: 19343846
• Product Code: LOX
• UDI-Device Identifier: 00613994902832
• UDI-Public: 00613994902832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/25/2018

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: 09/06/2020
• Device Catalogue Number: SPL25012X
• Device Lot Number: 213974055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 10/19/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 10/10/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR