MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F MP A1 (I) 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451406V0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, two tempo catheters (cath tempo 4f ber ii 65cm, cath tempo 4f mp a1 (i) 65cm, cath tempo 4f ber ii 65cm) became separated while being used with a non-cordis liver and biopsy set.The separated segments migrated to the lung arteries and were snared/retrieved using an unknown device.The devices were clinically used and will be returned for analysis.Three different cordis packages were returned with only two cordis catheters.It is unknown which lot corresponds with which catheter.The device did not kink in the area of separation.The device separated approximately 2.5cm and 2.3cm from the distal end.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Two devices were returned for evaluation.Neither device corresponds to the product reported under this complaint.It has been confirmed that there are no allegations against this device; therefore, no subsequent reports will be submitted.The event has been documented under 9616099-2019-03018 and 9616099-2019-03127.

• Brand Name: CATH TEMPO 4F MP A1 (I) 65CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8702379
• MDR Text Key: 148146030
• Report Number: 9616099-2019-03019
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032007778
• UDI-Public: 20705032007778
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 451406V0
• Device Catalogue Number: 451406V0
• Device Lot Number: 17834018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention