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

Catalog Number	NCEUP2512X
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Vascular Dissection (3160)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An nc euphora rx ptca balloon catheter was used to post-dilate a none tortuous, mildly calcified lesion exhibiting 90% stenosis in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device was passed through a previously deployed stent.Resistance was not encountered and excessive force was not used during delivery.Kissing balloon was performed post stenting in the bifurcation lad/diagonal.It was reported that after the balloon was inflated to 10atm it would not deflate at the lesion site.Deflation was attempted with multiple negatives.The balloon was removed while it was inflated by pulling with some force.It was indicated that the yellow tip section of the inner is missing.No patient injury reported.
Additional Manufacturer Narrative
Image review: an image of the device packaging pouch shows the device size and lot which match what was reported.An image shows the nc euphora shows a stretched balloon bond and a detached distal tip.An image shows the device hypotube and multiple kinks.An image shows the device hypotube shows multiple bends.An image of the hypotube and hub of the device shows multiple kinks on the hypotube.An image of the hub of the device was provided showing the luer connected to a stop cock.Angiographic images were returned for analysis.An image shows the lad and a lesion in the lcx.An image shows post dilation of a stent.An image shows multiple lesions visible in the vessel.An image shows a balloon inflated in vivo.Two guide wires are visible in the image and a deployed stent in the proximal vessel.An image shows the treated vessel.An image shows the treated vessel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
No difficulties noted during inflation.The device was not moved or repositioned prior to deflation difficulties.Deflation difficulties were noted on 2nd inflation.The kissing balloon was first inflated to 18atm and then deflated.The nc euphora balloon was then inserted in the lad and inflated to 6atm and deflated okay.He then went up with both balloons.The lad balloon was inflated to 18atm the fish balloon deflated and was removed and the lad balloon didn't deflate fully.The balloon was twisted to try and remove it.The balloon appeared to be fully inflated when removed from the patient.Concentration of contrast / saline is used by the physician was 50/50.The detached portion of the device was not removed from the patient as the physician was unaware of tip fracture until after procedure was finished when the patient was closed and removed from the procedure room.It is indicated that a dissection possibly occurred.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A 180 non-medtronic guidewire was used during procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: a stopcock was attached to the luer of the device.A kink was evident on the hypotube.There was a detachment on the distal tip, approx.1cm remained of the distal tip.The material at the detachment site appeared jagged and uneven.The balloon was partially inflated, and contrast was visible in the balloon.The proximal end of the balloon bond and the distal shaft immediately proximal to the balloon bond was necked and stretched.Deformation was evident to the exchange joint, the material appeared flared.It was not possible to inflate the balloon due to the necked and stretched balloon bond and distal shaft in order to perform deflation testing.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8690452
• Report Number: 9612164-2019-02280
• Device Sequence Number: 19334429
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: 00643169395930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: NCEUP2512X
• Device Lot Number: 216987246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 06/20/2019; 07/25/2019; 08/29/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/14/2019; 07/18/2019; 08/21/2019; 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR