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

Catalog Number NCEUP2520X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made use an nc euphoria balloon catheter to pre-dilate a moderately tortuous, severely calcified lesion, with 80% proximal stenosis and 90% distal stenosis, in the mid-distal left-anterior descending artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.There was no difficulty removing either the outer protective sheath covering the balloon, or the stylette.The balloon was prepped in the hoop to activate the hydrophilic coating.The device was inspected with no issues noted.(b)(6) prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.The device was not kinked or re-straightened during use.The balloon would not inflate.It is reported that a portion of the catheter detached during delivery through the vessel.The catheter was completely separated into two pieces at the site of balloon shaft fracture.This was noted as the balloon was being withdrawn from the patient via the sheath and only the proximal segment came out.The remaining distal segment was then visualized with fluoroscopy to confirm it¿s presence still in the body and it¿s location.The detached portion does not remain in the patient.Another nc euphorias device (2.0x20mm) was inflated to low pressure was used to trap the fractured catheter inside a 6f non-mdt catheter that was being used during the case.The 6f non-mdt catheter, the fractured balloon catheter and additional balloon were then removed from the body as a single unit with no complications.No patient injury is reported.

Manufacturer Narrative

Evaluation summary: the device returned with a detachment on the hypotube 48.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube 0.5cm , 2.5cm and 14cm proximal to the detachment site.It was not possible to perform inflation testing due to the detachment.There was no stretching to the balloon bonds.There was damage to the guide wire entry port.No other damage visible to the distal shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC EUPHORA 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: 7432115
• MDR Text Key: 105509839
• Report Number: 9612164-2018-00798
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396142
• UDI-Public: 00643169396142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Catalogue Number: NCEUP2520X
• Device Lot Number: 213895287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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: 68 YR
• Patient Weight: 127