MAUDE Adverse Event Report: CORDIS CORPORATION MAXI LD PTA F7 110 20X40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4162040L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the balloon of a 20mm x 40mm 110cm maxi ld f7 percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm), prior to being fully inflated.After confirming that there was no adverse effect on the patient, the device was removed, and a 20mm diameter non-cordis balloon catheter was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 70% esophageal stenosis.The target site was calcified but showed no signs of tortuosity.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced while during insertion of the device.The device was able to advance toward the lesion and cross the lesion without issue.The device was never put into an acute bend and did not kink during its use.After the balloon rupture, the maxi ld balloon catheter was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the contrast to saline ratio, length of the replacement balloon, and the completion of the procedure was requested but was not provided.The device was not returned as expected.

Event Description

As reported, the balloon of a 20mm x 40mm 110cm maxi ld f7 percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm), prior to being fully inflated.After confirming that there was no adverse effect on the patient, the device was removed, and a 20mm diameter non-cordis balloon catheter was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 70% esophageal stenosis.The target site was calcified but showed no signs of tortuosity.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced while during insertion of the device.The device was able to advance toward the lesion and cross the lesion without issue.The device was never put into an acute bend and did not kink during its use.After the balloon rupture, the maxi ld balloon catheter was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the contrast to saline ratio, length of the replacement balloon, and the completion of the procedure was requested but was not provided.The device was not returned as expected.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d4, g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the balloon of a 20mm x 40mm 110cm maxi ld f7 percutaneous transluminal angioplasty (pta) balloon catheter ruptured at six atmospheres (atm), prior to being fully inflated.After confirming that there was no adverse effect on the patient, the device was removed, and a 20mm diameter non-cordis balloon catheter was used as a replacement.There was no reported injury to the patient.This was during a procedure to treat a 70% esophageal stenosis.The target site was calcified but showed no signs of tortuosity.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced while during insertion of the device.The device was able to advance toward the lesion and cross the lesion without issue.The device was never put into an acute bend and did not kink during its use.After the balloon rupture, the maxi ld balloon catheter was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the contrast to saline ratio, length of the replacement balloon, and the completion of the procedure was requested but was not provided.The device was not returned for analysis as expected.A product history record (phr) review of lot 82233168 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 as the lesion was calcified with 70% stenosis.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 PTA F7 110 20X40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 14468724
• MDR Text Key: 292370024
• Report Number: 9616099-2022-05656
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032002278
• UDI-Public: (01)20705032002278(17)230331(10)82233168
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 4162040L
• Device Catalogue Number: 4162040L
• Device Lot Number: 82233168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Date Device Manufactured: 10/01/2021
• 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
• Treatment: HENGRUI CONTRAST; NON-CORDIS BALLOON CATHETER (20MM)
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG