MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 18X4 80CM; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis (b)(4) are respectively, (b)(4).This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

After deflation of a 7f 18x4 80cm maxi ld percutaneous transluminal angioplasty (pta) catheter, it would not come though the sheath.As the physician pulled on it, he snapped the shaft.There was no reported patient injury and the device will be returned for analysis.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.The lesion was not calcified and there was no vessel tortuosity.It was also not a chronic total occlusion (total occlusion >3 months.There was no difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was never in an acute bend and it deflated completely.Additional procedural details were requested but are not available.

Manufacturer Narrative

After deflation of a 7f 18x4 80cm maxi ld percutaneous transluminal angioplasty (pta) catheter, it would not come though the sheath.As the physician pulled on it, he snapped the shaft.There was no reported patient injury.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally (i.E.Maintain negative pressure.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.The lesion was not calcified and there was no vessel tortuosity.It was also not a chronic total occlusion (total occlusion >3 months.There was no difficulty advancing the balloon catheter through the vessel or difficulty crossing the lesion.The catheter was never in an acute bend and it deflated completely.Additional procedural details were requested but are not available.The device was not returned for analysis.A device history record (dhr) review of lot 17659066 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system withdrawal difficulty - through guide/sheath¿ and ¿body/shaft separated - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the withdrawal difficulty and separation could not be conclusively determined.Based on the limited information available for review, procedural/handling factors (pulling on the device when resistance was felt) may have contributed to the withdrawal difficulty and the subsequent body separation reported.According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintaining a vacuum on the balloon, withdraw the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: MAXI LD 7F 18X4 80CM
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6844500
• MDR Text Key: 84957246
• Report Number: 9616099-2017-01390
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 4171840S
• Device Lot Number: 17659066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/15/2017
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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