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

Catalog Number	SPL20015X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
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
An attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion in the diagonal branch.It was reported that the device detached, cracked or fractured.No patient injury reported.
Additional Manufacturer Narrative
The device was a sprinter legend rx ptca balloon catheter not a resolute onyx.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It is stated that everything was removed from the patient.The device was removed from the patient completely into the guide and sheath. no additional surgery or intervention was required to remove the device.Another balloon was used to complete the procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the hypotube 94.5cm distal to the strain relief.Several kinks were visible on the hypotube.Tactile testing confirmed kinks.The hypotube material was oval and jagged on both sides of the detachment site.There was no detachment of the balloon material.No other damage evident to the remainder of the device.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: 8217231
• Report Number: 9612164-2019-00052
• Device Sequence Number: 1656545
• Product Code: LOX
• UDI-Device Identifier: 00613994902122
• UDI-Public: 00613994902122
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• 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,Followup
• Report Date (Section B): 03/04/2019

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: 09/12/2021
• Device Catalogue Number: SPL20015X
• Device Lot Number: 216213897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 01/10/2019; 02/26/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/07/2019; 02/04/2019; 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR