MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD 7F 18X4 80CM; DILATOR, ESOPHAGEAL

Model Number	4171840S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of an 18mm x 40mm 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter ruptured during and inflation to 3 atmospheres (atm).As a result, the 8mm x 40mm 80cm maxi ld pta balloon catheter was replaced with 16mm x 4mm maxi ld balloon catheter which was used without issue to continue the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the iliac vein.There was no calcification or tortuosity at the target lesion, and the lesion was not a chronic total occlusion (cto).The device was stored and used per the instructions for use (ifu) and maintained negative pressure during preparation.A 50/50 contrast and saline mixture was used to prep the balloon.There was no difficulty removing the balloon hoop or protective cover during preparation.There was no difficulty experienced during insertion of the device, or while crossing the lesion.The device was not put into an acute bend during this procedure, and the device did not kink during its use.The device was able to be removed easily from the patient and remained in one piece during removal.The device will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82233176 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the balloon of an 18mm x 40mm 80cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter ruptured during and inflation to three atmospheres (atm).As a result, the 8mm x 40mm 80cm maxi ld pta balloon catheter was replaced with 16mm x 4mm maxi ld balloon catheter which was used without issue to continue the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the iliac vein.There was no calcification or tortuosity at the target lesion, and the lesion was not a chronic total occlusion (cto).The device was stored and used per the instructions for use (ifu) and maintained negative pressure during preparation.A 50/50 contrast and saline mixture was used to prep the balloon.There was no difficulty removing the balloon hoop or protective cover during preparation.There was no difficulty experienced during insertion of the device, or while crossing the lesion.The device was not put into an acute bend during this procedure, and the device did not kink during its use.The device was able to be removed easily from the patient and remained in one piece during removal.The device was not returned for analysis.A product history record (phr) review of lot 82233176 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely vessel characteristics and procedural factors may have contributed to the reported event.However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and the event reported.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 or preventive action will be taken at this time.

• Brand Name: MAXI LD 7F 18X4 80CM
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15232632
• Report Number: 9616099-2022-05904
• Device Sequence Number: 4693461
• Product Code: KNQ
• UDI-Device Identifier: 20705032002605
• UDI-Public: (01)20705032002605(17)230228(10)82233176
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K023907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 02/28/2023
• Device Model Number: 4171840S
• Device Catalogue Number: 4171840S
• Device Lot Number: 82233176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 08/19/2022
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 16MM X 4MM MAXI LD PTA BALLOON CATHETER.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG