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

Catalog Number NCSP3027X

Device Problem Deflation Problem (1149)

Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: device was returned loaded with three-way valve and with guidewire.Numerous kinks were visible on the hyoptube, transition tubing and distal shaft.Stretching was evident to the transition tubing and distal shaft.The balloon had become detached from the distal shaft and was not returned for analysis.Tear site of the balloon was located 1.1cm proximal to the proximal marker bands.Blood visible in the inflation lumen.The balloon material was jagged and uneven at the tear site.Negative prep and pressurisation was not performed due to detached balloon.Deformation was visible to the distal tip, with tip being badly stretched and torn.Inner lumen patency was not verified due to the severe stretching of the distal shaft.Continued from a1.Patient age reported as (b)(6) years.Exact date of birth unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used an nc sprinter balloon catheter to treat a lesion in the rca, not calcific or particularly tortuous with no abnormalities in anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.No difficulties noted when removing the protective sheath / packaging stylette from the device.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device passed through two previously deployed non-mdt stents in the mid and proximal rca.Excessive force was not used during delivery as the balloon passed easily to the distal part of the stents.It was reported that balloon deflation difficulties were encountered after the first inflation and the balloon would not deflate.The inflation device was changed and multiple techniques, such as non mdt guide extension catheters, non mdt guide wires and micro-catheters were used in an attempt to try deflate the balloon.The shaft of the balloon stretched as the physician was trying to retrieve it and felt like it was about to fracture.Eventually the physician deep throated the catheter and got the proximal end of balloon wedged into the guide, then pulled the guide and balloon out.The balloon was damaged during retrieval but may have been damaged outside the body, it was only observed at the very end as there was a lot going on.The balloon was missing and may have been in the guide or among the rest of equipment on the table.The customer confirmed that the balloon was inflated to 16-18atms prior to the deflation difficulties.The vessel was extensively dissected and the physician was unable to rewire the vessel.The patient has sustained a large mi but has survived.The mi occurred on the same day as the procedure.The physician believes that the mi was related to the balloon failing to deflate.Other equipment used: ar1, sion blue via lra.Guide wire and guide catheter also returning.

• Brand Name: NC SPRINTER RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6993476
• MDR Text Key: 90781678
• Report Number: 9612164-2017-01529
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: NCSP3027X
• Device Lot Number: 213421285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Date Device Manufactured: 06/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR