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

Catalog Number	EUP3020X
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/04/2019
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 euphora rx ptca balloon catheter to treat mildly tortuos, moderately calcified lesion located in the distal right coronary artery (rca).The device was inspected with no issues.The device was not kinked or re-straightened during use.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that the balloon was being used to pre-dilate the lesion however it could not be deflated at the lesion site and therefore removal difficulties were encountered.While attempting to pull the balloon wire and catheter out a detachment occurred from the balloon at the balloon shaft.The balloon portion of the device remained in the rca.The patient was sent to the operation room to have the remainder of the product removed surgically from the rca.The patient was reported to be alive with injury.
Additional Manufacturer Narrative
Add'l info: 50/50 concentration of saline/contrast was used by the physician.The device failed to deflate.No difficulties noted during inflation of the device.The device was not moved/re-positioned prior to attempting to deflate.One inflation was performed prior to noting deflation difficulty.The detached portion of the device was removed successfully during surgery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 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: 8498879
• Report Number: 9612164-2019-01257
• Device Sequence Number: 1966286
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 09/28/2020
• Device Catalogue Number: EUP3020X
• Device Lot Number: 216305198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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