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

Model Number 532598B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17723865) 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, during the incraft procedure, the radiopaque markers of the 5f super torque pig catheter (mb 110cm 6sh) came loose, preventing measurement and getting one of them inside the patient.The device will be returned for analysis.As of note: ¿per affiliate this is not the first time this happens¿.

Manufacturer Narrative

Event: additional information received indicates that the target lesion was abdominal aortic aneurysm.The vessel level of calcification and tortuosity is none.There was no stenosis in the arteries.The device was not used for a chronic total occlusion (cto) lesion.The device was stored and handled per the instructions for use (ifu).The device was in perfect condition and protected by packing.The product was prepped properly according to the ifu.The device was not prep properly since the beginning presented navigability problem with our wire (0,035 cordis hydrophilic wire).We noticed the problem at the time of measurement.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter was ok.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.The difficulty was navigating the wire inside in the catheter.It presented a lot of resistance and wasn´t the first case that happened with the catheter.The catheter was not torqued against resistance.There was no unusual force used at any time during the procedure.There was no kink/bend noted in the area of separation.A radiopaque catheter mark was inside the patient, but he was fine.There are no procedural films available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections b5, g4, g7, h2, h3 and h6 have been updated accordingly.Section b5: additional information received indicates that the product was prepped properly according to the instructions for use (ifu); however, since the beginning the device presented navigability problem with our wire (0,035 cordis hydrophilic wire).We noticed the problem at the time of measurement.The device preparing was normal, the problem began when the catheter was tracking on the guidewire, there was some resistance and after that the mark bands were wrong.There was no device separation, only the mark bands were disconnected.There was no issue with the 0.035 hydrophilic guidewire because other catheters were used in the same guidewire.During the incraft procedure, the radiopaque markers of the 5f super torque catheter (mb 110cm 6sh) came loose, preventing measurement and getting one of them inside the patient.There was no device separation, only the marker bands were disconnected.The product had been prepped properly according to the instructions for use (ifu).However, since the beginning, the device presented navigability problem with our wire (0,035 cordis hydrophilic wire).The problem was noticed at the time of measurement.The problem began when the catheter was tracking on the guidewire.There was some resistance and after that the marker bands were wrong.It presented a lot of resistance and was not the first case that happened with the catheter.The catheter was not torqued against resistance.There was no issue with the 0.035 hydrophilic guidewire because other catheters were used with the same guidewire.There was no reported patient injury.The target lesion was abdominal aortic aneurysm.The vessel level of calcification and tortuosity is none.There was no stenosis in the arteries.The device was not used for a chronic total occlusion.The device was stored and handled per the instructions for use (ifu).The device was in perfect condition and protected by packing.The catheter was not re-shaped by the user.There were no kinks or other damages noted prior to inserting the product into the patient.The catheter was ok.The catheter tip was visible on fluoro throughout the procedure.There was no difficulty tracking the catheter through the vessel or lesion.There was no unusual force used at any time during the procedure.There are no procedural films available.Four non-sterile units of super torque diagnostic catheters (cath mb 5f pig 110cm 6sh) were received for analysis coiled inside a plastic bag.Per visual analysis, 1 out of 4 catheters were observed offset/moved from their intended position.No anomalies were observed on 3 out of 4 catheters.On one unit, 14 out of 20 marker bands were found moved/out of position at the proximal section of the unit.The proximal section of the unit was observed under 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 14 marker bands (from mb 1 to mb 14) moved from their original place.Marker bands 15 to 20 remained in their original positions (the position of the marker bands is numerated from the hub to the distal end).No other anomalies were observed on that unit.The outer diameter (od) and inner diameter (id) of the proximal section was measured close to the areas where the marker bands were out of position and results were found within specification.Per functional analysis, a lab sample.038¿ emerald guidewire was inserted in the catheter via the hub.The emerald guidewire was stopped at 101cm from the hub due to the marker bands moved in this site, which is not intended.Also, the guidewire was inserted via the tip and it went through until it was stopped at 10.5cm from tip, also due to the marker bands moved in this site, which is not intended.The proximal 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.).A product history record (phr) review of lot 17723865 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿marker band (supertorque)- dislodged - in-patient¿ was not confirmed since marker bands were not observed dislodged or separated/out of any of the devices.The event reported by the customer as ¿marker band (supertorque) - offset/out of position - in-patient¿ was confirmed due to the marker bands were observed moved/out of their intended position on one of the received catheters.However, the exact cause of this condition could not be conclusively determined during the analysis since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.Results showed that the sections with evidence of marker bands displacement presented no anomalies or evidence as to determine what caused the marker bands movement; however, it can be assured that the marker bands were placed on the correct position at a certain time owing to the od reduction of the body.The noted tracking difficulty and resistance/friction with the concomitant guidewire may have contributed to the reported event.Interference or friction between devices (including all catheters, wires, sheath introducers, balloon/sds catheters) whether between one or multiple manufacturers product lines is a known occurrence.If resistance is encountered, the system should be withdrawn together as one unit to prevent injury.According to the ifu, although not intended as a mitigation, ¿avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.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.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque mb angiographic catheter positioning under high quality fluoroscopic observation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the phr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.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 CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9215758
• MDR Text Key: 167130151
• Report Number: 9616099-2019-03295
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032012031
• UDI-Public: 20705032012031
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17723865
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 02/20/2020
• Supplement Dates FDA Received: 11/18/2019; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening