MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F BER II 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451415V0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 BER II 65CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8702380
• Report Number: 9616099-2019-03020
• Device Sequence Number: 11231706
• Product Code: DQO
• UDI-Device Identifier: 20705032007877
• UDI-Public: 20705032007877
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 451415V0
• Device Catalogue Number: 451415V0
• Device Lot Number: 17835833
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/15/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention