MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN HYBRID ADJUSTABLE SLITTER; STYLET, CATHETER

Model Number 6232ADJ

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

The slitter was returned, analyzed and there was evidence of foreign material within the inner sterile package.

Event Description

It was reported that during the implant procedure and prior to opening the packaging of the slitter, foreign materials were observed inside the slitter and the black plastic part of the slitter appeared to be broken.It was noted the slitter was not opened and not used with the patient.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN HYBRID ADJUSTABLE SLITTER
• Type of Device: STYLET, CATHETER
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5860886
• MDR Text Key: 51829967
• Report Number: 2182208-2016-01993
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 06/15/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 6232ADJ
• Device Catalogue Number: 6232ADJ
• Device Lot Number: 46104016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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