MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during implantation of an aortic stent, the 110 cm.5 fr.Pigtail mb 6sh diagnostic catheter broke during the procedure inside the patient.The broken piece was successfully removed from the patient using a lasso catheter.The procedure was extended thirty (30) additional minutes.There was no reported patient injury.The product will not be returned for inspection.Additional information received indicated that the approach for the procedure was unknown.There was no reported difficulty advancing the product to the intended target lesion/location.There was no excessive manipulation/torquing of the device.It was not known if the product broke during manipulation/positioning of the device, or during withdrawal.The device was not re-sterilized.The entire broken portion was removed successfully.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.It was not known what was done to complete the procedure but the procedure was completed successfully.Procedural films are not available.Additional information was requested but was reported to be unknown.No additional information is available.

Manufacturer Narrative

During implantation of an aortic stent, the 110 cm.5 fr.Pigtail mb 6sh diagnostic catheter broke during the procedure inside the patient.The broken piece was successfully removed from the patient using a lasso catheter.The procedure was extended thirty (30) additional minutes.There was no reported patient injury.Additional information received indicated that the approach for the procedure was unknown.There was no reported difficulty advancing the product to the intended target lesion/location.There was no excessive manipulation/torquing of the device.It was not known if the product broke during manipulation/positioning of the device, or during withdrawal.The device was not re-sterilized.The entire broken portion was removed successfully.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.It was not known what was done to complete the procedure but the procedure was completed successfully.Procedural films are not available.Additional information was requested but was reported to be unknown.  the device was not returned for analysis.A device history record (dhr) review of lot 17610988 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.  the reported ¿catheter (body/shaft) separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.However, procedural factors may have contributed.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.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• 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 ave.; miami lakes, FL 33014
• MDR Report Key: 6215497
• MDR Text Key: 63630363
• Report Number: 9616099-2016-00820
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17610988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2016
• Date Manufacturer Received: 01/05/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention