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

Model Number	NCEUP22520X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: it was indicated that the nc euphora balloon shaft bent and broke when excessive force was placed upon it.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: facility name and address updated.If information is provided in the future, a supplemental report will be issued.
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 one nc euphora ptca balloon catheter to treat a lesion.It was reported that during routine percutaneous coronary intervention the balloon shaft broke off before entering the patients body.It was stated that intervention was required.It was reported that serious injury occurred.
Additional Manufacturer Narrative
Additional information: a tortuous, calcified lesion in the left anterior descending (lad) artery.Resistance was noted when advancing the device to the lesion and excessive force was used.It was reported that the detachment occurred during advancement of the device at the lesion.The balloon was not inflated.It was later stated that the detached portion of the device was successfully removed from the patient by pulling out along with device.It was also later stated that serious injury/intervention did not occur.The patient is reported to be alive.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: 9756995
• Report Number: 9612164-2020-00884
• Device Sequence Number: 11354372
• Product Code: LOX
• UDI-Device Identifier: 00643169396029
• UDI-Public: 00643169396029
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: NCEUP22520X
• Device Catalogue Number: NCEUP22520X
• Device Lot Number: 217271311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 04/15/2020; 05/19/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/22/2020; 05/27/2020
• 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