MAUDE Adverse Event Report: COOK INC CANTATA 2.9 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Customer reported that a cantata 2.9 super selective microcatheter cracked near the hub.The event occurred prior to use and prior to any patient contact.The device is reportedly available for evaluation.

Manufacturer Narrative

Investigation - evaluation: a review of device history record, drawing, specification, complaint history, instructions for use (ifu), quality control and visual inspections was conducted during on the returned product during the investigation.The customer reported that the microcatheter was fractured near the hub prior to use.Visual inspection showed that the catheter itself was actually kinked under the strain relief.A review of the complaint history revealed there were no related complaints.The device history record showed no nonconformances were reported related to the failure mode.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number 7788485.The risk specification document was reviewed for potential failure modes, causes and effects of failure, and current controls in place to mitigate the occurrence.One potential failure mode is kinking of the catheter shaft.The manufacturing process checks for any defects, so the damage may have occurred during shipping/packing or device preparation.Therefore, the root cause was determined to be inconclusive since there was no evidence to suggest the kink in the tubing occurred during shipping/packaging or device preparation.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6791299
• MDR Text Key: 82665863
• Report Number: 1820334-2017-02354
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.9-NT-110-15-HP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1