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

Model Number 532598B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During an endovascular repair of an aortic aneurysm (evar), it was reported that the gold marker of the super torque catheter moved upon removed.There was difficulty in removing catheter and it required more pulling than normally required.There was no patient injury.The user counted 20 marker bands on each catheter.The target lesion are the abdominal aorta and iliac arteries.Both lesion are moderately calcified and the iliac artery is severely tortuous.The device was stored, handled, and prepped per the instructions for use (ifu) with no defects noted during prep.Both pigtail catheters were introduced through a competitor's sheath introducer (16f and 18f).The catheter did not pass through a previously placed stent.The device was stored for six months.No other information was provided.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

During an endovascular repair of an aortic aneurysm (evar), the gold marker of the super torque catheter moved when the device was removed from the patient.There was difficulty in removing catheter and it required more pulling than normally required.There was no patient injury reported.Additional information was received and there was a second device returned where the marker bands were shifted.The user counted twenty marker bands on each catheter.The target lesions are the abdominal aorta and iliac arteries.Both lesions are moderately calcified, and the iliac artery is severely tortuous.The devices were stored, handled, and prepped per the instructions for use (ifu) with no defects noted during prep.Both pigtail catheters were introduced through a competitor's sheath introducer (16f and 18f).The catheters did not pass through a previously placed stent.The device were stored for six months.No other information was provided.The device was returned for analysis.Per visual analysis of the cath mb 5f pig 110cm 6sh all twenty marker bands were noted to be moved from their original positions and found piled up together after marker band number eight.All the marker bands were present at the catheter body, none were missing.The position of the marker bands is numerated from the distal end to the hub.The catheter body was noted to be elongated.No other damages or anomalies were noted.Per dimensional analysis, the inner diameter (id) and the outer diameter (od) of the body of the catheter were measured between the marker bands and the results were found out of specification due to the elongated condition noted.Per functional analysis, a lab sample guidewire was inserted into the catheter via the distal tip.The guide wire could not be passed through all the catheter body, this condition was caused due to the marker bands being out of position and the also due to the elongation condition.Per microscopic analysis, the device was observed under a microscope and the marker band marks on surface of the device did not present with evidence of damage (scratches, peelings, abrasions, etc.).No other issues were noted during microscopic analysis.A product history record (phr) review of lot 17728116 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¿ was confirmed.A marker band - offset/out of position condition was noted on the returned device.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 reported ¿catheter (body/shaft) - withdrawal difficulty¿ could not be properly evaluated due to the elongated condition of the catheter as received.The exact cause of the reported event could not be conclusively determined during the analysis.Vessel characters as well as procedural and handling factors might have contributed to this event.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 at this time.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8347348
• MDR Text Key: 140003216
• Report Number: 9616099-2019-02723
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• 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: 17728116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 78