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

Catalog Number 532598B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17644336) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while performing aaa procedure, the marked pig tail (cath mb 5f pig 110cm 6sh) diagnostic guide catheter got stuck inside the patient, therefore, the physician had to use force and use a lace device in order to remove a piece of pig tail from inside the patient.Also, the gold markers in the pig tail catheter moved from its original place.There was no reported patient injury.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, while performing aaa procedure, three marked pig tails ((cath mb 5f pig 110cm 6sh)) and three nylex (cath nylex 5f pig 100cm 8sh) diagnostic guide catheters got stuck inside the patient, therefore, the physician had to use force and use a lace device in order to remove a piece of pig tail from inside the patient.Also, the gold markers in all of the three pig tails catheters moved from their original place.There was no reported patient injury.Multiple attempts to gather additional information have been made and have been unsuccessful.A file with pictures of a cath mb 5f pig 110cm 6sh were received for analysis.Product was not returned.Per visual analysis of the received pictures, it can be observed that the marker bands were moved/offset-out of position, as well as, a piece of the catheter (distal section) was separated from the rest of the catheter.A review of the manufacturing documentation associated with lot 17644336 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The event reported by the customer as ¿marker band (supertorque)- offset/out of position - in-patient,¿ ¿catheter (body/shaft)- separated - in-patient,¿ and ¿catheter (body/shaft)- withdrawal difficulty¿ were confirmed since the marker bands were offset-out of position and a separated condition could be observed by the analysis of the received pictures.The cause of the event experienced by the customer could not be conclusively determined.However, procedural factors may have contributed to the reported event.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 analysis of the pictures suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.This is one of six products involved with the reported event and the associated manufacturer report numbers are mfr# 9616099-2017-01302, 9616099-2017-01304, 9616099-2017-01305, 9616099-2017-01306 and 9616099-2017-01307.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6773417
• MDR Text Key: 82043299
• Report Number: 9616099-2017-01303
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 532598B
• Device Lot Number: 17644336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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
• Treatment: - AAA DEVICE