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

Model Number 518-038

Device Problem Torn Material (3024)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device now available for evaluation.Evaluation methods, results and conclusions now available after device evaluation device was located on (b)(6) 2018 at the manufacturer and evaluated on (b)(6) 2018 after device had been misplaced since its delivery to the manufacturer on 07 june 2018.Visual inspection confirmed that the device is in two pieces, broken 14cm from the tip of the device.All marker bands are present.Distal tip has slight prolapse from use; there appears to be stretched scratches observed near the tear where the device had dragged against something on the proximal side of the break.Some light kinks were observed on the device.16cm from the proximal side of the break, more heavy scratching is observed in the working length.When final catheter drawing was reviewed, it showed that the point of breakage was approximately where the necking of the tubing began.Due to the amount of damage to the catheter, it cannot be determined if the tubing broke proximal or distal to where the necking began.

Manufacturer Narrative

Initial reporter's state inadvertently initially recorded as (b)(6).This field now edited to reflect the accurate state of (b)(6).

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO
• MDR Report Key: 7610902
• MDR Text Key: 284178169
• Report Number: 1721279-2018-00075
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• PMA/PMN Number: K033678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/25/2019
• Device Model Number: 518-038
• Device Catalogue Number: 518-038
• Device Lot Number: FQR17C25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Treatment: NO SPECTRANETICS CONCOMITANT DEVICES LISTED
• Patient Outcome(s): Other
• Patient Age: 65 YR