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

Model Number 6215

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, during prep of cath lab material, it was not possible to feed the guidewire through the lumen of the balloon catheter.It was noted the balloon was also defective.A different balloon catheter was used to complete the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter was returned and analyzed.Analysis indicated that the mechanical operation of the balloon catheter infusion lumen was occluded.Visual analysis of the lead indicated damage during use.The analyst noted that the balloon catheter was returned with the syringe still connected.There was appeared dried contrast on the catheter shaft, and also covered the catheter tip.Dried contrast was removed to prepare to inflate the balloon.Balloon could be inflated.Then guidewire insertion was performed.Because the guidewire was not returned, a guidewire sample was used.The guidewire could not pass through the lumen at distance 75cm.Destructive analysis was performed, a piece of dried contrast obstruct inside the infusion lumen was found, and that related to the guidewire insertion complaint reported.If information is provided in the future, a supplemental report will be issued.

• 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: 8922738
• MDR Text Key: 155266137
• Report Number: 2182208-2019-01542
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K012225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061660449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• 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: Initial
• Patient Sequence Number: 1