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

Catalog Number EUP3530X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An nc euphora rx ptca balloon catheter was used during a procedure to treat a severely calcified lesion in the right coronary artery (rca).There was no damage noted to the packaging.The device was removed from the hoop with no issues.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon did not deflate at all and could not be removed, attempts with an additional gw and snare were unsuccessful, while trying to retrieve the balloon the catheter tore/fractured up from the balloon but the balloon remains still inflated in the rca.The patient had an mi and was not stable.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation summary: the device returned with a detachment on the hypotube 33.5cm distal to the strain relief and a detachment 87cm distal to the strain relief on the transition shaft.The hypotube material was oval and jagged on both sides of the detachment site.The transition shaft material at the detachment site was jagged and uneven.Kinks were evident on the hypotube 6.2cm proximal to the detachment site and 2.3cm distal to the detachment site.Deflation testing could not be performed as the most distal detached section of the device did not return for analysis.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The relevant device which was previously reported as an nc euphora, is a 3.5x30mm euphora rx ptca balloon catheter.The rca was stented during a previous pci and was now occluded.The stenosis was crossed with a guidewire, and was dilated in several steps.A 3.0x20mm euphora balloon was used successfully.The 3.5x30mm euphora was first inflated to 7 atm and could not be deflated.Then the balloon was inflated to 20 atm to try to burst the balloon with no success.While attempting different manipulations and pullback to retrieve the balloon, the catheter detached from the balloon.The small mi occurred because of a thrombus in a side branch.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 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: 9314744
• MDR Text Key: 166141139
• Report Number: 9612164-2019-04731
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141090
• 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,Followup,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Catalogue Number: EUP3530X
• Device Lot Number: 214444488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• 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): Hospitalization; Required Intervention