MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 16X6 80CM; DILATOR, ESOPHAGEAL

Catalog Number	4171660S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The maxi ld 16x6 80cm balloon ruptured during the procedure.There were no reported patient injuries.The target lesion was a fibrous iliac vein.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.The same indeflator used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon inflated normally.The balloon was inflated to nominal pressure.The balloon catheter was removed easily.A non-cordis balloon was used to complete the procedure.The device was not returned for analysis.A product history record (phr) review of lot 82159289 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ and ¿packaging/pouch/box removal difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of a fibrous vein and procedural factors such as difficulty removing the device from the storage hoop may have contributed to the reported event.According to the safety information in the instructions for use ¿open the pouch, take the hub and gently take the catheter out.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.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.¿ neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the maxi ld 16x6 80cm balloon ruptured during the procedure.There were no reported patient injuries.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.The same indeflator used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon inflated normally.The balloon was inflated to nominal pressure.The balloon catheter was removed easily.The target lesion was a fibrous iliac vein.A non-cordis balloon was used to complete the procedure.The device will not be returned for analysis.

• Brand Name: MAXI LD 16X6 80CM
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8252638
• Report Number: 9616099-2019-02639
• Device Sequence Number: 2124744
• Product Code: KNQ
• UDI-Device Identifier: 20705032002582
• UDI-Public: 20705032002582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 4171660S
• Device Lot Number: 82159289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 66