MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532598C

Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

During an unknown procedure, the radiopaque markers on the distal part of the 5f super torque catheter stayed in the artery of the patient while removing the catheter.No other information was reported.The device was not returned for analysis.A product history record (phr) review of lot 17644344 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) dislodged - in-patient¿ could not be confirmed as the device was not returned for analysis and procedural films were not received.The exact cause could not be determined.Vessel characteristics, while unknown, and procedural/handling factors such as excessive force used, may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation, ¿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.¿ the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the radiopaque markers on the distal part of the 5f super torque catheter stayed in the artery of the patient while removing the catheter.

Manufacturer Narrative

After further review of additional information received the following sections d10, g4, g7, h2, and h6 have been updated accordingly.During an unknown procedure, the radiopaque markers on the distal part of the 5f super torque catheter stayed in the artery of the patient while removing the catheter.No other information was reported.The device was returned for analysis.A non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag.All marker band were present on the catheter body, none were missing.Per visual analysis was observed that 10 out of the 20 marker bands were moved from their original position and they were found piled up together.The device presented with elongation on catheter body of 15 cm of length near of the eleventh marker band.Only marker bands 1 to 10 remained in their original positions.Per functional analysis, a.038¿ emerald guidewire lab sample was inserted into the catheter via the tip.The emerald guidewire could not be passed all the way through the catheter body, this was caused due to the marker bands being out of position.Per microscopic analysis, and the marker band marks on the surface of the device did not present with evidence of damage (scratches, peelings, abrasions, etc.).Per dimensional analysis, the inner diameter (id) and outer diameter (od) of the body shaft was measured between the marker bands.The od between marker bands 15 to 20 was found within specification, the results of marker bands 10 to 15 were found out of tolerance since this corresponds to the elongated area.No other anomalies were found.A product history record (phr) review of lot 17644344 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 event reported as ¿marker band (supertorque) - dislodged in patient¿ was not confirmed, since all marker bands were present on the device.However, a ¿marker band - offset/out of position¿ condition was noted.The exact cause of this condition could not be conclusively determined during the analysis.Per the elongations found on catheter body it was determined that this may have been the cause of marker band migration.The exact cause of the elongations could not be determined.Vessel characteristics, while unknown, and procedural/handling factors such as excessive force used, may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation, ¿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.¿ the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: SUPER TORQUE CATH MB 5F PIG 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8121242
• MDR Text Key: 128946373
• Report Number: 9616099-2018-02564
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/25/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 532598C
• Device Lot Number: 17644344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening