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

Model Number 532598B

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18102380 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, a 5f pigtail 110cm 6sh (sideholes) super torque catheter ruptured when it was removed over an unknown guidewire during an endovascular aneurysm repair (evar).There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, and h10 this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.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 have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 5f pigtail 110cm 6sh (sideholes) super torque catheter ruptured when it was removed over an unknown guidewire during an endovascular aneurysm repair (evar).There was no reported patient injury.Addendum: during the product evaluation it was noted the unit was separated at two pieces, both segments were returned and markers band 19 and 20 are dislodged and were not returned for analysis.The device was returned for analysis.A non-sterile unit of product ¿cath mb 5f pig 110cm 6sh¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to perform the product evaluation.The unit is separated at two pieces, and both segments were returned.The separation is located approximately at 26 cm from the distal tip.Also, the unit presents markers band out of position and dislodged.The marker bands 10, 11, 12, 13, 14, 15 16, 17 and 18 present an offset/out of position condition.The markers band 19 and 20 are dislodged and were not returned for analysis.(the position of the marker bands is numerated from the distal end to the hub).Per dimensional analysis: the dimension of the id and od on the body shaft was measured close to the areas where the marker bands are out of position.The dimensional analysis results were found out of specification.The results indicate that the unit is elongated and with the diameter reduced below the lower spec.Additionally, a dimensional analysis was performed near the separate edges.Measurements were taken near at one cm from the separated edges of the two pieces.The diameter is below the lower spec.This result indicate that the unit is as well elongated at this area.Per functional analysis, an 0.038¿ lab sample guidewire was inserted inside the catheter via the distal tip at the distal segment.The guide wire could not be passed through the entire segment, this condition was caused due to the marker bands out of position reduced inner diameter.The marker bands were inspected with a vision system in order of obtain a magnify image.No anomalies or damages were observed.Per microscopic analysis, the cath mb 5f pig 110cm 6sh catheter complaint unit body presented evidence of a separation condition where material elongation patterns were observed across the separation borders of the body separation, this type of damage is commonly caused during the exposure of an excessive tensile force that may cause these types of mechanical damages.It is very likely that the related factors to an excessive force applied in the affected area could probably led to the damaged condition found on the received device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 18102380 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft)- burst - in-patient¿ was not confirmed, no burst condition was observed on the returned unit.However, ¿catheter (body/shaft) - separated - in-patient¿ and ¿marker band - dislodged¿ was confirmed.With the limited information provided it is not possible to determine an exact cause for the event.Catheter separation failures are commonly associated with elongations caused by material tensile overload.Therefore, it is assumed that the catheter was induced to a tensile force that exceeded its material yield strength prior to the separation.It was also indicated that the catheter was blocked on the non-cordis guidewire and was unable to be advance over the non-cordis guidewire.Procedural factors such as proper flushing of the device, vessel characteristics or entrapment of the catheter between other endovascular devices and the vessel wall may have contributed to this issue.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to 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.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.¿ based on the information available, the device analysis and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported, a 5f pigtail 110cm 6sh (sideholes) super torque catheter ruptured when it was removed over an unknown guidewire during an endovascular aneurysm repair (evar).There was no reported patient injury.The device will be returned for evaluation.Addendum: during the product evaluation it was noted the unit was separated at two pieces, and both segments were returned.The separation is located approximately at 26 cm from the distal tip.The markers band 19 and 20 are dislodged and were not returned for analysis.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16019717
• MDR Text Key: 308540443
• Report Number: 9616099-2022-06172
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18102380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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: UNKNOWN GUIDEWIRE.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG