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

Model Number N/A

Device Problems Difficult to Remove (1528); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17550183) presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.

Event Description

It was reported that during a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure, it was difficult to pull the pig tail catheter into the lock to extract due to the gold markers having shifted.The catheter did not tear off.There was no reported patient injury.The device was not used to treat a chronic total occlusion (cto).The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty advancing the device to the target lesion or crossing the target lesion.The device passed through some acute bends.All of the marker bands were retrieved from the patient and accounted for.Additional procedural details were requested but are unknown.

Manufacturer Narrative

It was reported that during a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure, it was difficult to pull the pig tail catheter into the lock to extract due to the gold markers having shifted.The catheter did not tear off.There was no reported patient injury.The device was not used to treat a chronic total occlusion (cto).The device was stored and handled per the instructions for use (ifu).The device was prepped per the instruction for use (ifu).There was no difficulty advancing the device to the target lesion or crossing the target lesion.The device passed through some acute bends.All of the marker bands were retrieved from the patient and accounted for.Additional procedural details were requested but are unknown.A non-sterile unit of cath mb 5f pig 110cm 6sh diagnostic catheter was received for analysis coiled inside a plastic bag.Per visual analysis, 16 out of 20 marker bands were found moved/out of position at the distal section of the unit.The distal section of the unit was observed under the vision system and the marker band marks on the unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).However, the unit presented with an elongation on the catheter body from 24 cm to 26.5 cm from the distal tip.Elongated length measured 2.5 cm.The catheter showed 16 marker bands (from mb 5 to mb 20) moved from their original place.Marker bands 1 to 4 remained in their original positions (the position of the marker bands is numerated from the distal end to the hub).The catheter length was measured and the result was 110.5cm long.No other anomalies were found.The od and id of the distal section was measured close to the areas where the marker bands were out of position and results were found within specification.A.038¿ emerald guide wire lab sample was inserted in the catheter via the tip.Emerald guide wire was stopped at 94.7 cm from the hub due to the marker bands moved in this site.Also, the guide wire was inserted via the tip and it went through until it was stopped at 14.5 cm from the tip.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.The event reported by the customer as ¿catheter (body/shaft) - withdrawal difficulty¿ could not be confirmed due to the nature of the complaint.However, the event reported by the customer as ¿marker band-offset/out of position - in-patient¿ was confirmed due to the offset marker bands on the received catheter.The cause of the event experienced by the customer could not be conclusively determined.However, procedural factors may have contributed to the reported event as evident by elongations which could be attributed to tensile forces.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 device history record review nor the product analysis suggests that the event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• 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: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6547109
• MDR Text Key: 74495251
• Report Number: 9616099-2017-01078
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Device Lot Number: 17550183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/10/2017
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• 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