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

Model Number 518-065

Device Problems Break (1069); Material Separation (1562)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth and age unavailable patient's weight unavailable.

Event Description

A peripheral atherectomy procedure commenced to treat a total vessel occlusion (severely calcified) in the patient's mid anterior tibial artery.The physician chose to use a spectranetics quick-cross support catheter as a guide catheter.Accessing from a retrograde approach (accessing against the usual direction of blood flow), the physician was attempting a wire exchange; however, he could not get the quick-cross catheter removed from the patient.The tip of the quick-cross, approximately 2.5cm, tore off inside of the patient while attempting removal.It was presumed that it became caught on something within the vessel, since the vessel was found to be totally occluded prior to the procedure.The physician attempted to snare the remnant of the quick-cross catheter, but the snares were too large.The physician decided to forego removing the portion of the quick-cross and it remained within the patient's vasculature.At that time, the physician attempted to use a second quick-cross catheter.The physician had access in the anterior tibial artery, which was occluded proximal to mid segment and he was attempting to cross the lesion.He was able to pass a 0.014" wire through the lesion but he then wanted to exchange the wire for a lighter support wire so he could use a 1.8 phoenix device in order to treat the patient's occlusion.He then advanced the quick-cross catheter but the catheter would not cross the lesion.When the physician attempted to "walk" the catheter out, it stretched to the point that it tore as well.An approximate 1.5cm segment was left within the patient's vasculature, from this second quick-cross catheter.He chose to abandon the procedure at this time.It was reported that the patient did not undergo further invention and since the artery was confirmed to be totally occluded, the physician was monitoring the patient for further complications.The two portions of the quick-cross catheters reportedly remained in the patient vasculature.This report captures the second quick-cross catheter in which an approximate 1.5cm remnant remained in the patient's vessel.Please refer to mdr 1721279-2020-00184 which captures the first quick-cross catheter used which tore during the procedure, leaving a remnant within the patient as well.

• 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10482815
• MDR Text Key: 207702798
• Report Number: 1721279-2020-00185
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K072750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: 518-065
• Device Catalogue Number: 518-065
• Device Lot Number: FQV20D21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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): Hospitalization; Required Intervention