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

Catalog Number	SPL30020X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/01/2019
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 a procedure an attempt was made to use a sprinter legend rx ptca balloon catheter.The device was inspected with no issues noted.Negative prep was performed without issue.It was reported that a detachment occurred.The detached portion of the device was removed using a snare.Patient is alive with no further injury reported.
Additional Manufacturer Narrative
The lesion was in the mid rca, was calcified with minimal tortuosity.Lesion stenosis was 90%.The lesion was predilated.Resistance was noted during delivery and withdrawal of the device.Excessive force was used.Sufficient time was given for the balloon to deflate prior attempting to remove the device from the patient.The detachment occurred at the proximal end of the device during withdrawal.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the sprinter legend rx ptca balloon catheter was being used to pre-dilate a lesion.It was reported that the balloon burst during the procedure.The balloon burst on first inflation at 19 atm.The detached portion of the device is not available for return.Evaluation summary: the device returned with a detachment of the inner member; 129.4 cm distal to the strain relief and a detachment of the balloon material; 152.9 cm distal to the strain relief.The detached inner member, section of the balloon and tip were not returned for analysis.The inner member material was jagged at the detachment site, the balloon material appeared slightly jagged at the detachment site.A kink were evident on the hypotube 0.7 cm proximal to the detachment site.Deformation was evident to the exchange joint.No other damage evident to the remainder of the device.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: 8615191
• Report Number: 9612164-2019-01777
• Device Sequence Number: 13955811
• Product Code: LOX
• UDI-Device Identifier: 00613994901552
• UDI-Public: 00613994901552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P790017
• 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): 08/20/2019

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: 02/11/2022
• Device Catalogue Number: SPL30020X
• Device Lot Number: 217112582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 07/09/2019; 08/19/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/17/2019; 08/07/2019; 08/20/2019
• 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: 69 YR
• Patient Weight: 98