MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number 6215

Device Problems Break (1069); Burst Container or Vessel (1074); Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the balloon catheter was returned and analyzed.The analysis indicated that the mechanical operation of the balloon catheter was occluded.There was an issue with the catheter shaft.The balloon was ruptured.Blood was observed on the shaft of the delivery catheter.Visual analysis of the balloon catheter indicated damage during use.The analyst noted the balloon catheter was returned without the inflation syringe and the coronary wire.There is blood at the distal tip orifice of the balloon catheter.The balloon is ruptured on the balloon catheter.A guidewire was inserted into the balloon catheter and came to an occlusion at 39 cm.Blood and contrast occluded the shaft of the balloon catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implant procedure, the balloon catheter would not allow the coronary wire to pass through and exit the catheter lumen.The catheter was not used and another was used.The catheter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN VENOGRAM BALLOON CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10311045
• MDR Text Key: 199987754
• Report Number: 2182208-2020-01329
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 6215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR