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

Model Number	518-037
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unavailable from the facility.The device was discarded.Therefore no evaluation can be performed.
Event or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Upon further review, it was determined that the information listed in the initial mdr and supplemental report #1 were incorrect.Block d2) the common device name was updated to catheter, percutaneous (from quick-cross).Block d4) the udi was updated to (b)(4) (from (b)(4).Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 9153759
• Report Number: 1721279-2019-00169
• Device Sequence Number: 2694112
• Product Code: DQY
• UDI-Device Identifier: 00813132020682
• UDI-Public: (01)00813132020682(17)210326(10)FQQ19C26A
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 06/11/2024
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/22/2019; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 01/01/2005