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

Catalog Number SPL25020X

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use one sprinter legend rx ptca balloon catheter to treat a mildly tortuous, moderately calcified lesion exhibiting 75% stenosis in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.It was reported that a leak in the luer/hub occurred during first balloon inflation at 12 atm.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: the luer of the sprinter legend was connected to a pressure pump during negative prep.The luer of the sprinter legend was inspected before attaching to non-medtronic inflation device with no issues noted.No crack was noted prior to attaching the luer of the sprinter legend to the non-medtronic inflation device.The luer of the sprinter legend was connected to directly a non-medtronic inflation device with no issues noted.A crack in the luer interface was noted.Device evaluation summary: device returned for evaluation.Kinks were evident on the hypotube of the device.There was a longitudinal crack evident on the front of the luer.A mould line was evident on the back of the luer.Deformation was evident to the distal shaft.The balloon folds were expanded; the balloon had been inflated.Contrast was visible inside the balloon.The device failed negative prep.It was not possible to inflate the device due to the crack on the luer.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10065461
• MDR Text Key: 191553565
• Report Number: 9612164-2020-01899
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Catalogue Number: SPL25020X
• Device Lot Number: 218503504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 05/16/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 05/21/2020; 05/16/2020
• Supplement Dates FDA Received: 06/09/2020; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60