MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 22X4 110CM; DILATOR, ESOPHAGEAL

Catalog Number 4172240L

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17687068) 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 maxi ld pta balloon catheter was inflated in a calcified rv to- postero-anterior (pa) conduit without incident.A secured inflation was performed and the balloon ruptured.The physician was called to retrieve the balloon with a snare.The balloon fragment was retrieved with no harm to the patient.The melody valve was placed without incident.There was no reported patient injury.The device will be return for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, a 7f 22x40mm 110cm maxi ld pta ballon catheter was inflated in a calcified rv to- postero-anterior (pa) conduit without incident.A secured inflation was performed and the balloon ruptured.The physician was called to retrieve the balloon with a snare.The balloon fragment was retrieved with no harm to the patient.The competitor valve was placed without incident.There was no reported patient injury.The target lesion was the pulmonic valve.The vessel level of calcification is severe.The vessel level of tortuosity is none.The vessel level of stenosis is 50%.The device was not used for a chronic total occlusion (cto) lesion.The device stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device was prepped per the instructions for use (ifu).The device was prep normally.There were no anomalies noted during or after the device was prepped, second indeflation was where the rupture occurred, brought the balloon back more proximal after first inflation and deflation.The balloon ruptured on second indeflation, tore in half when trying to remove from the sheath, and for a while it was still intact.Tore off still on wire, then embolized all the way through to the pulmonary artery.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.The maximum inflation pressure was rbp not over.The balloon did maintain pressure during inflation.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The device was torn in half after removed from patient.There was no kink/bend noted in the area of separation.The middle of the balloon ruptured.There was no unusual force used at any time during the procedure.The product was not removed intact (in one piece) from the patient.A non-cordis balloon used after the maxi ruptured too when treating the same lesion.The main problem is that the balloon wouldn¿t come out of the sheath even when they up-sized, and then it tore trying to come out and launched through the patient¿s bloodstream, ending up in the pulmonary artery after going through the right atrium and right ventricle.There was no patient injury.A part of the one non-sterile unit of maxi ld 7f 22x4 110cm was received inside a plastic bag.The balloon was separated at 5cm from distal tip.No other anomalies were observed.Functional test could not be performed due to the condition of the received unit.The unit was sent to sem analysis in order to analyze the potential cause of the damages.Results showed that the external surface of balloon presented evidence of scratches and abrasion marks near the balloon separation and it¿s very likely that the same factors that caused these damages on the balloon¿s outer surface could have also contributed to the rupture/separation found on the received balloon.The internal surface did not present any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17687068 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon separated in patient¿ were confirmed through analysis of the returned device.However, the exact cause of the failures reported by the customer could not be determined during the analysis.Based on the information available for review, lesion characteristics (severely calcified valve) most likely contributed to the burst reported since calcified/resistant lesions can damage the balloon as evidenced by the scratches found during sem analysis.Handling factors (trying to pull a ruptured balloon through a sheath) likely contributed to the separation reported.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.According to the ifu, which is not intended as a mitigation, ¿the maxi ld pta catheter is intended to dilate stenoses in peripheral arteries below the aortic arch.The rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.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.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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections b5, d10, d11, g4, h2 and h3 have been updated accordingly.Event: additional information received indicates that the target lesion was the pumonic valvue.The vessel level of calcification is severe.The vessel level of tortuosity is none.The vessel level of stenosis is 50%.The device was not used for a chronic total occlusion (cto) lesion.The device stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device was prepped per the instructions for use (ifu).The device was prep normally.There were no anomalies noted during or after the device was prepped, second indeflation was where the rupture occurred, brought the balloon back more proximal after first inflation and deflation.The balloon ruptured on second indeflation, tore in half when trying to remove from the sheath, and for a while it was still intact.Tore off still on wire, then embolized all the way through to the pulmonary artery.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.The maximum inflation pressure was rbp not over.The balloon did maintain pressure during inflation.There was no difficulty tracking the catheter through the vessel or lesion.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The device was torn in half after removed from patient.There was no kink/bend noted in the area of separation.The middle of the balloon ruptured.There was no unusual force used at any time during the procedure.The product was not removed intact (in one piece) from the patient.A non-cordis balloon used after the maxi ruptured too when treating the same lesion.The main problem is that the balloon wouldn¿t come out of the sheath even when they upsized, and then it tore trying to come out and launched through the patient¿s bloodstream, ending up in the pulmonary artery after going through the right atrium and right ventricle.There was no patient injury.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: MAXI LD 7F 22X4 110CM
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7664176
• MDR Text Key: 113240599
• Report Number: 9616099-2018-02234
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 4172240L
• Device Lot Number: 17687068
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: - ATLAS BALLON; - CONTRAS MEDIA (OPTIRAY 320); - INDEFLATOR DEVICE (MERIT)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability