MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

Model Number 518-036

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A pt with conglomerative retroperitoneal mass was undergoing an inferior vena cava recanalization with stent placement, the distal end of the quick cross catheter broke off.The broken piece of the catheter was successfully retrieved.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5337144
• MDR Text Key: 35253535
• Report Number: 1721279-2015-00196
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/24/2016
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: FQP14L24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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): Required Intervention