MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F BER II 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451515H0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.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, the tempo catheter (5f ber ii 100cm) broke in two pieces inside the patient.There was no injury to the patient.The catheter was retrieved with a snare.The catheter was used in a popliteia artery that was very calcified.The catheter was clinically used and will be returned for analysis.Photos of the broken catheter were made available.

Manufacturer Narrative

Complaint conclusion: during use, a tempo catheter (5f ber ii 100cm) broke into two pieces inside the patient¿s heavily calcified popliteal artery.There was no reported patient injury.The catheter was retrieved with a snare.No other information was provided.The device was returned for analysis.A non-sterile cath tempo 5f ber ii 100cm was received inside a plastic bag.Per visual inspection, a separation was noted at 46.8 cm from the distal end.Per dimensional analysis, the catheter¿s (inner diameter) id and (outer diameter) od were found within specification.Per sem results, the catheter presented with twisted conditions and a separation at 46.8 cm from the distal end.Distal and proximal separated sections presented with evidence of twisted conditions and elongations.The separated wires showed plastic deformation that results in a surface type of cup and cone and also presented with ductile dimples.No other anomalies were observed during sem analysis.A review of the manufacturing documentation associated with lot 17690641 was performed and no issues were noted that were related to the reported event.The event reported by the customer as ¿catheter (body/shaft) - separated¿ was confirmed.The exact cause of the damage could not be conclusively determined during the analysis.Dimensional analysis results were found within specification and do not suggest that this damage could be related to the manufacturing process.Sem analysis suggests that the device was induced to an excessive application of tension and torsion force that resulted in the separation.Procedural and handling factors, as well as vessel characteristics (heavily calcified) may have contributed to this event.According to the instructions for use (ifu), which is not intended as a mitigation ¿torqueing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer.¿ neither the phr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the device.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 5F BER II 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 7506686
• MDR Text Key: 107992834
• Report Number: 9616099-2018-02125
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 06/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 451515H0
• Device Catalogue Number: 451515H0
• Device Lot Number: 17690641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention