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

Catalog Number	SPL20015X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event summary: the device was returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon proximal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a tear on the balloon material immediately proximal to the proximal marker band.The balloon material was jagged and uneven at the tear site.Lead in scratches were evident distal to the tear site.No deformation was evident to the distal tip.The inner lumen patency was verified.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a sprinter legend rx ptca balloon catheter to treat a mildly calcified and moderately tortuous lesion located at the proximal first obtuse marginal artery exhibiting 80-90% stenosis.There were no abnormalities in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that the balloon ruptured during the first inflation at 6 atm.It was described that the balloon was removed without issue.The physician used another balloon to dilate the lesion with no issues.Patient status post procedure is alive with no injury.
Additional Manufacturer Narrative
Additional information: the device was not moved or re positioned prior to the burst.There was a sudden drop in pressure noted on the inflation device and that was how they recognised that the balloon ruptured.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient's medical history includes allergies to penicillins.It was reported that balloon was inflated to 0atm for 19secs.The balloon was noted to be ruptured.The physician used another sprinter legend otw inflated initially to 10atm for 31 sec and then reinflated to 8 atm for 31 secs to dilate the lesion with no issues.The physician proceeded to deploy 2 non-mdt des devices to complete the procedure.Inclusion of race medtronic, inc.( 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: 7193533
• Report Number: 9612164-2018-00075
• Device Sequence Number: 16373186
• Product Code: LOX
• UDI-Device Identifier: 00613994902122
• UDI-Public: 00613994902122
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 03/14/2018

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: 06/06/2020
• Device Catalogue Number: SPL20015X
• Device Lot Number: 213464254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/21/2018; 02/17/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/12/2018; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 67