MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF 3DRC 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 538476

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2020

Event Type  Injury  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with lot 17899610 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, the distal tip of 4f 100cm 3-dimensional right coronary (drc) infiniti diagnostic catheter was detached from the catheter body after removing the device from a 4f non-cordis sheath.The scrub tech informed the physician and the physician assumed that the "foreign body" was still on the wire and possible inside the sheath.However, after doing fluoroscopy up from the femoral artery to the aorta they were unable to find the "foreign body" in both femoral and in the aorta.They continue doing the fluoroscopy down the right iliac and they "found the foreign" body was secured in the profunda artery.They then completed the left ventriculogram (lvgram) and removed the sheath, holding a manual compression , physician was called in to remove the catheter tip.The physician went in the left common femoral artery and removed the foreign body by getting an 0.014" wire through the tip.He then ran a small balloon into the tip, inflated, and successfully removed the tip.No adverse patient effects, outside of the secondary surgery.The procedure was left heart catheterization after a right coronary angiogram.A 0.035" unknown guidewire was inserted through the infiniti 3drc catheter.The catheter was removed from the patient over the wire, through the sheath in the common femoral artery.The case had gone smoothly up to that point.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.As reported, the distal tip of the 4f infiniti diagnostic catheter was detached from the catheter body after removing the device from a 4f non-cordis sheath.The scrub tech informed the physician and the physician assumed that the "foreign body" was still on the wire and possibly inside the sheath.However, after doing fluoroscopy up from the femoral artery to the aorta, they were unable to find the "foreign body" in both femoral and in the aorta.They continued doing the fluoroscopy down the right iliac and they found the foreign body was secured in the profunda artery.They then completed the left ventriculogram, removed the sheath, and held manual compression.The physician was called in to remove the catheter tip.The physician went in the left common femoral artery and removed the foreign body by getting an 0.014" wire through the tip.He then ran a small balloon into the tip, inflated, and successfully removed the tip.No adverse patient effects, outside of the secondary surgery.The procedure was left heart catheterization after a right coronary angiogram.A 0.035" unknown guidewire was inserted through the infiniti 3drc catheter.The catheter was removed from the patient over the wire, through the sheath in the common femoral artery.The case had gone smoothly up to that point.A non-sterile unit of an infiniti diagnostic catheter (cath f4 inf 3drc 100cm) was received for analysis coiled inside of a clear plastic bag.Per visual analysis, a separated condition was observed on the returned unit located at 101 cm from the proximal end.The separated segment was not returned for analysis.No other damages or anomalies were found.The dimensions of the inner diameter (id) and outer diameter (od) were measured.Measurements were taken at one cm from the separated edge.Dimensional analysis results were found within specification.Per microscopic analysis, the edges of the separated section presented evidence of elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the separation.No other issues were noted during microscopic analysis.A product history record (phr) review of lot 17899610 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) - separated in patient¿ was confirmed, a separated condition was observed on the body of the returned catheter.Exact cause of the separation could not be conclusively determined during the analysis.Procedural/handling factors may have contributed to the reported event.The elongations found on the edges of the separated section suggest that the device was induced to stretching/pulling or twisting events that exceeded the material yield strength prior to the separation.Per the instructions for use (ifu), which not intended as a mitigation of risk, ¿exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the phr review nor the product analysis suggests that the found conditions could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH F4 INF 3DRC 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9834762
• MDR Text Key: 190011481
• Report Number: 9616099-2020-03562
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032014929
• UDI-Public: 20705032014929
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 538476
• Device Catalogue Number: 538476
• Device Lot Number: 17899610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Weight: 81