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

Catalog Number	EUP2515X
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
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
During a procedure a euphora rx ptca balloon catheter was intended to be used to treat a lesion.There was no damage noted to the packaging.The device was inspected with no issues noted.It was reported that difficulties were encountered removing the stylette and protective cover which resulted in a tear in the scrub personnel's glove and damage to the balloon.It was reported that the balloon was not functional after removal of stylette and protective cover.
Additional Manufacturer Narrative
Product analysis summary: the sheath and stylette did not return for analysis.No deformation was evident to the distal tip.Contrast was visible in the balloon.The balloon was deflated, the balloon folds were expanded.There was no damage evident to the balloon.The proximal balloon bond was necked and stretched.It was not possible to perform inflation or deflation testing due to the condition of the proximal balloon bond.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the device was used in the patient.The scrub replaced the glove before they continued on with the procedure.The balloon was inserted into the lesion and inflated as normal.However the balloon was slow to inflate.At this point it was known that the device was not functioning properly and negative pressure was performed.The balloon would not deflate.Eventually enough contrast/flush solution was removed to carefully remove the device from the lad lesion.No damage to the vessel was angiographically evident.The target lesion was then stented and post dilated with a good result.The patient was not harmed and is doing fine.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: 8915473
• Report Number: 9612164-2019-03509
• Device Sequence Number: 16832531
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2019

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: 06/05/2021
• Device Catalogue Number: EUP2515X
• Device Lot Number: 217850427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 09/12/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/18/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9612164-09-12-2019-001-R
• Patient Sequence Number: 1