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

Catalog Number	SPL12506X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Uf/importer report# (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
They physician was attempting to use one sprinter legend balloon catheter to treat a lesion located in the left circumflex artery during pci procedure.The device was inserted through the guide catheter into the lesion.It was reported that on inflation, the balloon ruptured and broke off in the lesion.The physician carried out multiple attempts to remove the balloon fragment ultimately resulting in embolization of the balloon fragment.The physician decided to leave the fragment in place.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: physician commented that the event was related to the anatomy and not the balloon.The lesion was in a difficult retro flexed lcx that was balloon uncrossable.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: 6663251
• Report Number: 9612164-2017-00808
• Device Sequence Number: 11233303
• Product Code: LOX
• UDI-Device Identifier: 00643169271746
• UDI-Public: 00643169271746
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2018
• Device Catalogue Number: SPL12506X
• Device Lot Number: 210065458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 08/30/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR