MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot was performed and the following was found: review of lot 17522228 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.8 defective units were rejected during the assembly of this lot.The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.

Event Description

During the procedure, a catheter (mb 5f pig 65cm 8sh) broke in its middle.No consequence for the patient.The product will be returned for analysis.Request for additional information has been made.

Manufacturer Narrative

Complaint conclusion: as reported, during the procedure, a supertorque catheter (mb 5f pig 65 cm 8sh) broke in its middle.There was no reported negative consequences to the patient.Attempts to gather additional information were unsuccessful.The product was not returned for analysis.Review of lot 17522228 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the product instructions for use, manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Furthermore, if resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm the catheter positioning under high quality fluoroscopic observation.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6095539
• MDR Text Key: 59739991
• Report Number: 9616099-2016-00720
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 17522228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2016
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1