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

Model Number 532598B

Device Problems Detachment Of Device Component (1104); Structural Problem (2506)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot 17610987 revealed no anomalies during the manufacturing and inspection processes that can be associated with 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

As reported by the nurse, the pig catheter broke during a case while it was inside the patient.The physician also observed that the band markers on the catheter were loose and moved.The most proximal marker also moved.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies notes when the device was removed from the package.The device was prepped per the ifu.There were no anomalies noted during prep.There was some resistance met while withdrawing the device.The physician had to use a snare to retrieve the distal portion of the catheter out.All 20 markers were accounted for.The device did not kink in the area of separation.Additional procedural details were requested but are unknown.

Manufacturer Narrative

As reported by the nurse, the pig catheter broke during a case while it was inside the patient.The physician also observed that the band markers on the catheter were loose and moved.The most proximal marker also moved.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies notes when the device was removed from the package.The device was prepped per the ifu.There were no anomalies noted during prep.There was some resistance met while withdrawing the device.The physician had to use a snare to retrieve the distal portion of the catheter out.All 20 markers were accounted for.The device did not kink in the area of separation.Additional procedural details were requested but are unknown.A non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag.The catheter body was separated at 24.5 cm from its distal end and one of the separated sections presented a compressed condition at the separation section.Also, 1 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.).The catheter showed 1 marker band (mb 20) moved proximal from its original place.The rest of the marker bands 2 to 20 remained in their original positions (the position of the marker bands is numerated from the distal end to the hub).No other anomalies were found.Sem analysis was performed to determine the possible cause of the catheter body separation.Sem results showed that the separated sections of the outer member presented elongations and frayed edges.Also, compress condition was observed on one of the separated sections.These characteristics presented evidence as a product of an application of a tension force that induced the separation.The inner and outer diameter (id and od) of the catheter body's inner shaft  was measured between marker band 1 and marker band 2 and id result was found within the minimal lower specification, however, od was found out of specification; this suggested an elongation condition in this section of the catheter.Review of lot 17610987 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.  the complaint reported by the customer as ¿catheter body shaft - separated - in-patient¿ was confirmed as the product was received.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.

Manufacturer Narrative

(b)(4).

• 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: 6370665
• MDR Text Key: 68750467
• Report Number: 9616099-2017-00931
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915836
• 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,Followup
• Report Date: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 17610987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/05/2017
• Initial Date Manufacturer Received: 02/05/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided; 10/20/2017
• Supplement Dates FDA Received: 03/14/2017; 10/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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
• Patient Outcome(s): Required Intervention