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

Model Number 518-065

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a slightly calcified, fibrous lesion in the patient''s mid posterior tibial (pt) artery.A spectranetics quick-cross support catheter was used to cross the lesion.It was reported that a pedal approach was used.Both the anterior tibial (at) and the pt arteries were severely tortuous.During the procedure, it was observed that the quick-cross developed a hole.The physician discontinued use of the quick-cross, additional catheters were opened, and the procedure was completed with no reported patient harm.This report captures the quick-cross in which a hole was observed during use, potential for harm.

Manufacturer Narrative

Patient''s date of birth, age unk.The device has been returned to the manufacturer, but the evaluation has not yet begun.A supplemental mdr will be submitted when device evaluation and investigation are completed.

Manufacturer Narrative

B5): this event is no longer reportable after device evaluation and investigation completed.G3): the device evaluation and investigation were completed on 12 may 2022.H3): the device was returned and evaluated by a cross functional team.Biologics were seen throughout the quick-cross device.The quick-cross was wavy in appearance 3.5 inches from its distal tip, as if the device was pushed up against hard material causing the quick-cross''s material to wave.Just proximal to the tip, there was a slight bulge in the quick-cross, but no significant damage was observed.All marker bands were present.Using water, the inner lumen was flushed.Water was seen leaking out of the inner lumen distal to the proximal hub.The quick-cross was twisted and kinked with multiple holes observed; this damage extended 2 cm from the proximal hub.H6): the damage likely occurred due to twisting motion and excessive force, causing the twists, kinks and holes.This has been determined to be a use related failure.

Event Description

This event is no longer reportable for hole in catheter - potential for harm.Per the returned device analysis, the damaged areas of the quick-cross were found to be on the portion of the device near the proximal hub (not within the working length).

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14366003
• MDR Text Key: 299954480
• Report Number: 1721279-2022-00095
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20813132021720
• UDI-Public: (01)20813132021720(17)240811(10)FAE21H10A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072750
• 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,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-065
• Device Catalogue Number: 518-065
• Device Lot Number: FAE21H10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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
• Treatment: GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE, MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American