MAUDE Adverse Event Report: CORDIS CASHEL SLALOM PTA .018 HP 40 6X4; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4396040T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: a slalom.018 hp 40 6 x 4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used, but it ruptured during its initial inflation.There was no reported patient injury.It was replaced with a same size balloon and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17636408 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 device was not returned for analysis.The exact cause could not be determined.There is no additional information regarding patient, lesion or procedural characteristics regarding this event.With the paucity of information available and without the return of the product or films of the procedure it is not possible to draw a clinical conclusion between the device and the event.However, vessel characteristics and procedural factors may have contributed to the reported event.According to the instruction for use, which are not intended to mitigate risk, ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Caution: if strong resistance is met during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.Remove the vacuum (do not apply pressure) and withdraw the catheter.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of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated.If not, withdraw the catheter and sheath as one unit.¿ neither the phr nor the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.

Event Description

As reported, a slalom.018 hp 40 6x4 percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used, but it ruptured during its initial inflation.There was no reported patient injury.It was replaced with a same size balloon and the procedure was completed.The slalom pta bc was discarded in the hospital due to infectious diseases.

• Brand Name: SLALOM PTA .018 HP 40 6X4
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8508895
• MDR Text Key: 141765904
• Report Number: 9616099-2019-02846
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 4396040T
• Device Catalogue Number: 4396040T
• Device Lot Number: 17636408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2017
• 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