MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER

Model Number 472-110-002

Device Problems Device Expiration Issue (1216); Device Operates Differently Than Expected (2913)

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

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the working length is pulled back into the braided shaft.The device does not extend or retract on the ramp.Flattened section on the tail tube present.

Event Description

Patient procedure involving use of a turbo-tandem device.A complaint was generated reporting that the laser catheter did not go back from the ramp.Upon entering the complaint information into the data base, the lot # of the device was also recorded, which reflects the device's manufactured date.It was discovered at this time that the device was used past its expiration date, which is two years from the manufactured date.This expiration date is printed on the device label.Case was completed without adverse event and patient was discharged per operative plan.

• Brand Name: SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER
• Type of Device: TURBO-TANDEM
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6577015
• MDR Text Key: 75612207
• Report Number: 1721279-2017-00093
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K094036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2017

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: Physician
• Device Expiration Date: 04/13/2017
• Device Model Number: 472-110-002
• Device Catalogue Number: 472-110-002
• Device Lot Number: FBY15D08A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 60