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

Catalog Number	NCEUP3520X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a nc euphoria rx ptca balloon catheter to treat a moderately tortuous, moderately calcified lesion exhibiting 90% stenosis in the mid right coronary artery (rca).The device was inspected with no issues noted.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It is reported that the balloon would not deflate at the lesion site.It is indicated that the balloon was inflated to 20atm to burst the balloon as intervention.No other patient injury reported.
Additional Manufacturer Narrative
Additional information: 50/50 concentration of saline / contrast was used.No difficulties reported removing the protective sheath and packaging stylet from the device.A non-medtronic guide wire was used.A buddy wire was not used.There was no issue during inflation.It is reported that the balloon would not deflate at the lesion site after the first inflation.A guide extension catheter (gec) was used to attempt to dislodge the inflated balloon.The balloon was inflated to 8 atm initially, then an attempt was made to deflate.The balloon was inflated to 16 atm and another attempt was made to deflate.It was decided to inflate to 20 atm (rated burst pressure) as intervention.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: a non-medtronic guide extension catheter was received with the device.Stretching was evident to the distal shaft.The strain relief appeared curved.Deformation was evident to the distal tip.The balloon was deflated.There was blood visible in the balloon.The proximal balloon bond and the distal shaft material immediately proximal to the balloon bond appears to have inflated and burst, the material was twisted.The material at the burst site was jagged and uneven.Deformation was evident to the distal shaft.Crystallised contrast was visible in the inflation lumen.A slight kink was evident at the exchange joint.It was not possible to inflate the balloon to perform deflation testing due to the burst distal shaft and proximal balloon bond.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: 8683144
• Report Number: 9612164-2019-02259
• Device Sequence Number: 19410493
• Product Code: LOX
• UDI-Device Identifier: 00643169396326
• UDI-Public: 00643169396326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2019
• Device Catalogue Number: NCEUP3520X
• Device Lot Number: 214382576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 07/25/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/05/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR