MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 18X6 80CM; DILATOR, ESOPHAGEAL

Catalog Number 4171860S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when a 7f maxi ld pta balloon catheter (16x4 80cm) was advance within the venous stent and inflated (x2) at the proximal end of the stent, the maxi balloon ruptured within the stent on the second inflation.Then, another 7f maxi ld pta balloon catheter (16x4 80cm) was advance within the same stent and the balloon ruptured on the first inflation; consequently, the physician advanced 7f maxi ld pta balloon catheter (18x6 80cm) into the same stent and inflated at the distal end of the stent (x2) and the balloon ruptured on the second inflation.There was no reported patient injury.The target lesion was the right iliac vein.The vessel level of angulation, calcification and tortuosity is none.The devices were prepped per the instructions for use (ifu).The devices were prep normally.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices and a 20-cc syringe was used.The balloons inflated normally for the 1st inflations but would rupture during subsequent inflations.The device was used in iliac vein, so it was inflated with 20cc syringe and just inflated enough to oppose the stent up against the wall.The catheters were not torqued against resistance.There were no kink/bent noted after the devices were removed from patient.There was no unusual force used at any time during the procedure.The devices were removed intact (in one piece) from the patient.There is no procedural film/cd available for review.As reported: ¿the lab director said this has been happening more frequently with the maxi¿s.They were using wall stents and this wasn¿t happening as frequent but now they are using a non-cordis stent.The devices will not be returned for evaluation as the devices were discarded by the hospital.

Manufacturer Narrative

When a 7f maxi ld percutaneous transluminal angioplasty (pta) balloon catheter (16x4 80cm) was advanced within the venous stent and inflated (x2) at the proximal end of the stent, the maxi balloon ruptured within the stent on the second inflation.Another 7f maxi ld pta balloon catheter (16x4 80cm) was advanced within the same stent and the balloon ruptured on the first inflation; consequently, the physician advanced 7f maxi ld pta balloon catheter (18x6 80cm) into the same stent and inflated at the distal end of the stent (x2) and the balloon ruptured on the second inflation.There was no reported patient injury.The target lesion was the right iliac vein.The vessel level of angulation, calcification and tortuosity is none.The devices were prepped normally per the instructions for use (ifu).The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices and a 20-cc syringe was used.The balloons inflated normally for the 1st inflations but would rupture during subsequent inflations.The device was used in iliac vein, so it was inflated with 20cc syringe and just inflated enough to oppose the stent up against the wall.The catheters were not torqued against resistance.There were no kink/bent noted after the devices were removed from patient.There was no unusual force used at any time during the procedure.The devices were removed intact (in one piece) from the patient.As reported: ¿the lab director said this has been happening more frequently with the maxi¿s.They were using wall stents, and this wasn¿t happening as frequent but now they are using a non-cordis stent.The product was not returned for analysis.A product history record (phr) review of lot 82163173 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Without the return of the products for analysis it is difficult to draw a clinical conclusion between the devices and the reported events.However, vessel characteristics and procedural factors such as intra-stent inflation may have contributed to the reported events.The stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent and during balloon inflation.According to the safety information in the instructions for use ¿note: 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.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected site.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the phr 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.This is one of three products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-03109, 9616099-2019-03110 and 9616099-2019-03111.

• Brand Name: MAXI LD 7F 18X6 80CM
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 8850886
• MDR Text Key: 197294764
• Report Number: 9616099-2019-03111
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 20705032002629
• UDI-Public: 20705032002629
• Combination Product (y/n): N
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2020
• Device Catalogue Number: 4171860S
• Device Lot Number: 82163173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRAST MEDIA (VISIPAQUE); WALL STENTS
• Patient Age: 71 YR