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

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the user facility, a 5f 110cm supertorque pigtail catheter with 6 side holes could not be retrieved, as expected, as part of an intervention to eliminate an infrarenal abdominal aortic aneurysm, due to a tear in the distal part within the sheath.Subsequently, the catheter fragment and the sheath (cordis avanti 5 fr.Ref 504-605x, lot 17793930) had to be removed.The torn fragment was contained within the sheath when the devices were removed as a unit.The surgery was extended by 30 minutes and the patient had no complications at the end of the procedure.It was also reported that the radiographically detectable distance markers periprocedural slipped, which seems to be a multi-lot problem.The patient was thus exposed to additional, even though minor, blood loss and the potential risk of vascular dissection as part of the required reinsertion of the sheath with concomitant surgery time extension.The material has been stored and is ready to be picked up by the manufacturer.The lesion being treated was an infrarenal abdominal aortic aneurysm with a maximum diameter of 5.5 cm known.The lesion was not calcified.There was little vessel tortuosity and vessel angulation.There was no stenosis present.The device was therefore not used for a chronic total occlusion (total occlusion >3 months).There were no anomalies noted when removed from the package and no anomalies noted during prep.There was no difficulty removing the catheter or no resistance met while withdrawing the supertorque catheter.There was no excessive force used while attempting to remove the catheter.

Manufacturer Narrative

During an abdominal aortic aneurysm procedure, a 5f 110cm supertorque pigtail catheter with 6 side holes could not be retrieved, as expected, due to a tear in the distal part within the sheath.Subsequently, the catheter fragment and the sheath (cordis avanti 5 fr.Ref 504-605x, lot 17793930) had to be removed.The torn fragment was contained within the sheath when the devices were removed as a unit.The surgery was extended by 30 minutes and the patient had no complications at the end of the procedure.It was also reported that the radiographically detectable distance markers slipped periprocedural.The patient was thus exposed to additional, even though minor, blood loss and the potential risk of vascular dissection as part of the required reinsertion of the sheath with concomitant surgery time extension.The lesion being treated was an infrarenal abdominal aortic aneurysm with a maximum diameter of 5.5 cm.The lesion was not calcified.There was little vessel tortuosity and vessel angulation.There was no stenosis present.The device was therefore not used for a chronic total occlusion (total occlusion >3 months).There were no anomalies noted when the device was removed from the package and no anomalies were noted during prep.There was no difficulty removing the catheter or no resistance met while withdrawing the supertorque catheter.There was no excessive force used while attempting to remove the catheter.No other information was reported.The device was returned for analysis.One unit of a cath mb 5f pig 110cm 6sh was received for analysis inside a plastic bag.Per visual analysis a separation was noted at 25 cm from distal end as well as marker bands #17-20 were noted to be moved from their original position; marker bands #1-16 were found with no anomalies.The position of the marker bands is numerated from the distal end to the hub.The separated area was observed under vision system and evidence of elongation was noted.The outer diameter (od) and inner diameter (id) of the device were measured between the marker bands affected and results were found within specification parameters; however, od results were found out of specification due to elongation of distal area.Per functional analysis, an attempt to introduce a guide wire into the device was unsuccessful due to the separated condition of the device as received.Per microscopic analysis, the device was inspected under vision system and the separated area and external edge surfaces at the separation area showed definitive evidence of elongations at separation.Per sem analysis, results it is showed that separated area on body shaft of the catheter presented with evidence of elongations and diameter reduction.The elongations and diameter reduction found on the body shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body shaft material was induced to a tensile force that exceeded the body shaft material yield strength prior to the separation.No other issues were noted during sem analysis.A product history record (phr) review of lot 17730715 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿marker band (supertorque) offset/out of position - in-patient¿, ¿catheter (body/shaft) withdrawal difficulty¿, and ¿brite tip/distal tip ¿ catheters separated - in-patient¿ were confirmed due to the catheter separation, od reduction and elongations noted on the device as received.However, the exact cause of these conditions could not be conclusively determined during the analysis.The separated section presented with evidence of elongations at the separation.However, the sections with evidence of marker band displacement presented with no anomalies or evidence as to determine what caused the marker band movement; nonetheless, it can be assured that the marker bands were placed on the correct position at a certain time owing to the outer diameter reduction of the body.As per the warnings in the instructions for use (ifu), ¿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.This product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

• 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
• MDR Report Key: 8492847
• MDR Text Key: 141242516
• Report Number: 9616099-2019-02836
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Device Lot Number: 17730715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 63 YR