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

Model Number 518-037

Device Problem Material Separation (1562)

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

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Patient information is unavailable from the facility.The device was discarded.Therefore no evaluation can be performed.

Event Description

A philips representative reported that during a peripheral atherectomy case, the tip of the catheter broke off in the im artery.Physician used an x-ray and saw 3 radiopaque markers were visible.He tried to use a snare to retrieve the tip, but was unsuccessful due to size of the artery.The procedure was abandoned.

Event Description

Additional information was received (b)(6) 2019 from the rep regarding the event: clarification provided that the im artery was the inferior mesenteric artery.The artery was extensively calcified at the entry point.The quick-cross catheter got caught on the calcium at the origin of the artery.The catheter tip broke off before a stent was placed.

Manufacturer Narrative

A2): patient age provided.A3): patient sex provided.A4): patient weight provided b3): event date corrected to (b)(6) 2019.B5): additional event information provided b7): patient medical history provided.D4): device lot number, expiration date, and udi corrected; numbers provided on initial mdr were incorrect d11): therapy date corrected to reflect (b)(6) 2019.Section e: physician email now obtained h4): device manufacture date corrected.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9153759
• MDR Text Key: 161710413
• Report Number: 1721279-2019-00169
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: 518-037
• Device Catalogue Number: 518-037
• Device Lot Number: FQQ19C26A
• Was Device Available for Evaluation?: No
• 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: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 82