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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned but the engineering report is pending. a device history record review was not performed because the sterile lot number is unknown.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During an evar case a 5f supertorque pigtail marker band 10 cm 6sh catheter broke into 2 pieces at the bifurcation of the external iliac/aorta.The physician removed the first part but the distal part stayed in the aorta.He noticed that the gold markers were also jammed together on the pigtail. a snare was successfully used to retrieve the second part.The patient is reported to be ¿ok¿ but lost 1 liter of blood extra because of the time extra for this procedure. the broken device is available to be returned.The device broke at the bifurcation of the external iliac/aorta it was a very tight bifurcation and when he pushed hard and the pigtail broke in 2 pieces. there were no anomalies noted when removed from the package and no anomalies during prep.The lesion was severely calcified, moderately angulated, unknown stenosis and moderate vessel tortuosity. the device was not used for a chronic total occlusion (total occlusion >3 months). there was resistance met while advancing the device. the snare was used to retrieve the part of the catheter that was in the aorta. there was no treatment provided for the blood loss. films are not available.Additional patient and procedural details were requested but are unknown.

Manufacturer Narrative

During an endovascular aneurysm repair (evar) case, a 5f supertorque pigtail marker band 110cm 6sh catheter broke into two pieces at the very tight bifurcation of the external iliac/aorta.The physician was trying to cross the vessel, but there was no torque response so the user kept trying, even turned the pigtail on itself for better response, and it broke in two within the patient when the user pushed hard.The physician removed the first part but the distal part stayed in the aorta.He noticed that the gold markers were also jammed together on the pigtail, ¿like if the pigtail wasn¿t graduated anymore¿.A snare was successfully used to retrieve the second part; however, it was reportedly not easy.The patient is reported to be ¿ok,¿ but lost one liter of blood extra because of the time extra for this procedure.There was no treatment provided for the blood loss.There were no anomalies noted when removed from the package and no anomalies during prep.The lesion was severely calcified, moderately angulated, unknown stenosis and moderate vessel tortuosity.The patient was an (b)(6) male.The device was not used for a chronic total occlusion (total occlusion >3 months).There was resistance met while advancing the device.Films are not available.Additional patient and procedural details were requested but are unknown.One non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag along with its original inner pouch.Per visual analysis, the catheter shows 5 marker bands (mb16 ¿ mb20) moved from its original place (moved/ out of position) and 4 of them piled up together.Marker bands 1 to 15 remained in their original positions.The position of the marker bands are numerated from the distal end to the hub.Also, the received catheter was found separated in two sections that were received for analysis.The catheter body separation was found at 25.1cm from catheter distal end.The distal section of unit was observed under vision system and the marker band marks on unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).The catheter body separated areas were observed under vision system and the separated edges presents elongation characteristics.The separated catheter body was sent to sem analysis and results showed that the catheter body separated sections presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.No other issues were noted during sem analysis.Catheter length was not measured due to the separated condition found on catheter body.The catheter id and od of body shaft was measured between marker bands and results were found within specification.A.038¿ emerald guide wire lab sample was inserted in the catheter via tip.Emerald guide wire was stopped at 18.6cm from distal end due to the marker band pile-up in this site.A device history record (dhr) review was not conducted as a lot number was not provided.The reported ¿catheter (body/shaft) - resistance/friction - in-patient,¿ ¿catheter (body/shaft) - separated - in-patient¿ and ¿marker band (supertorque) - offset/out of position-in patient¿ were confirmed through analysis of the returned product.However, the cause of the issues reported could not be conclusively determined during analysis.Based on the information available for review, vessel (very tight bifurcation) and procedural/handling (physician ¿pushed hard¿ against resistance) factors likely contributed to the resistance/friction, marker band movement, and separation reported as evidenced by elongations noted during analysis.According to the products instructions for use, users are warned that 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.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Neither the product analysis nor the information available suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventive action will be taken.

• Brand Name: CATH MB 5F PIG 110CM 6SH SUPERTORQUE MARKERBAND CATHETER
• Type of Device: DIAGNOSTIC CATHETER
• 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: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6562898
• MDR Text Key: 75017293
• Report Number: 9616099-2017-01090
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/18/2017
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention