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

Catalog Number NCSP3015X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

Device returned for evaluation.Kinks were noted on the hypotube.There was a detachment on the hypotube 24.2cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.The balloon folds were intact.No inflation had been performed.No damage was noted to the distal tip.No other damage evident to the remainder of the device.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 nc sprinter rx ptca balloon catheter to treat a moderately tortuous, moderately calcified lesion exhibiting 80% stenosis located in the ostium of the right coronary artery (rca) and the right posterior descending (r-pda) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon failed to cross through patent struts in the pda to perform kissing at bifurcation technique.The patient was reported to be alive with no injuries.

Manufacturer Narrative

Additional information: procedural image review shows an attempt to deliver the nc sprinter.It appears that positioning difficulties are encountered.The nc sprinter is removed before a different balloon is seen to be delivered to the pda.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: NC SPRINTER RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 12031188
• MDR Text Key: 257160777
• Report Number: 9612164-2021-02392
• 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
• Report Date: 07/08/2021

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: 08/20/2021
• Device Catalogue Number: NCSP3015X
• Device Lot Number: 218328433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 83