MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN CLARITY; CATHETER, FLOW DIRECTED

Model Number 6225

Device Problems Deflation Problem (1149); Material Rupture (1546)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, a balloon catheter would not deflate after the third inflation attempt.The balloon catheter ruptured and all pieces were completely removed from the patient.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the full catheter was returned and analyzed.The balloon catheter was found to be ruptured, and the mechanical operation of the catheter shaft was kinked/buckled.The catheter was damaged during use.The analyst noted that the inflation openings are located on the outer edge of the arc formed by the kink, and the balloon had a longitudinal tear along the outer edge of the arc formed by the kink.The balloon was still adhered on the proximal and distal ends, and dried, shiny material was observed near proximal inflation opening but was not actually in the opening.Spectrographic analysis found a protein and another unidentifiable component which had a strong iodine signal (analyst commented that iodinated substances are commonly used in contrast solutions).A small amount of dried, dull material in the formation of dots was observed in the balloon port.(b)(4).

• Brand Name: ATTAIN CLARITY
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4460605
• MDR Text Key: 15904211
• Report Number: 9612164-2015-00128
• Device Sequence Number: 1
• Product Code: DYG
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2015
• Device Model Number: 6225
• Device Catalogue Number: 6225
• Device Lot Number: 0007194750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 00075 YR
• Patient Weight: 100