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

Catalog Number	SPL15020X
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/16/2018
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
During the procedure, an attempt was made to use one sprinter legend rx coronary ptca balloon catheter to treat a severely tortuous and calcified lesion exhibiting 99% stenosis located in the mid lad.The device was inspected with no issues.(b)(6) prep was performed with no issues.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.Resistance was encountered when advancing the device however excessive force was not used.It was reported that during the procedure the balloon was inflated to 8atm and a balloon rupture occurred inside the patient.The mid marker band dislodged into the septal perforator coronary artery.Balloon debris and the mid marker band remain inside the patient.The procedure was completed by rotational atherectomy and stenting.The patient was discharged.The patient is reported to be alive with injury.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Add info: there was attempt to remove the marker band from the patient¿s body.The patient did not suffer any injury.Product analysis summary: the device returned with blood visible in the balloon and inflation lumen.The distal tip was detached.The material at the detachment site was jagged and uneven.Damage was evident to the balloon material at the burst site.The inner member was severely stretched.There was a detachment of the balloon material.The material at the detachment site was jagged and uneven.The mid marker was not present.There was no 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: 8004220
• Report Number: 9612164-2018-02924
• Device Sequence Number: 1386479
• Product Code: LOX
• UDI-Device Identifier: 00613994902467
• UDI-Public: 00613994902467
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/06/2019

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: 09/26/2020
• Device Catalogue Number: SPL15020X
• Device Lot Number: 214098679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 01/17/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/26/2018; 02/06/2019
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 57