MAUDE Adverse Event Report: CORDIS CASHEL SABER 2.5MM10CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002510S

Device Problems Balloon (419); Shaft (955); Burst Container or Vessel (1074); Detachment of Device or Device Component (2907); Catheter (3038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the physician attempted to dilate a stenosis in the patient¿s iliac artery using a saber (2. 5mm 10cm 90) balloon catheter when they noticed a rapid decrease in balloon pressure. It then became evident that the balloon had ruptured. Upon further inspection, it was noticed that a piece of the balloon material was stuck inside the patient¿s artery. A snare was required to retrieve the broken balloon material. The device was stored and handled per the instructions for use (ifu). The product looked normal when removed from its packaging. The device was prepped normally (i. E. Maintain negative pressure). There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The contrast to saline ratio was approximately 50/50 in the balloon. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. The device was not used for a chronic total occlusion (total occlusion >3 months). There was no difficulty advancing the balloon catheter through the vessel. The access site was the ipsilateral femoral. There was >50% calcification, no tortuosity, and tight stenosis. There was no acute bends nor tortuosity. There was no difficulty crossing the lesion. The catheter was never in an acute bend. There was no unusual force used at any time during the procedure until after the balloon ruptured. The device did not have to pass through a previously placed stent. The balloon inflated normally multiple times. There was no leakage noted from the balloon, shaft, hub, or unknown segment. The balloon inflated 3 or 4 times prior to the burst. The balloon ruptured at around 15 atmospheres (atm). There was no resistance removing the balloon catheter; however, the balloon ruptured and separated at the same time and remained inside the patient. The balloon catheter did not kink while being used. It was further clarified that the balloon was ripped, and the catheter portion of the balloon telescoped open (described as telescoping shaft within a shaft). It had come undone lengthwise. There was no further injury to the patient.

• Brand Name: SABER 2.5MM10CM 90
• 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: 8010873
• MDR Text Key: 125274264
• Report Number: 9616099-2018-02464
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/26/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/29/2020
• Device MODEL Number: 48002510S
• Device Catalogue Number: 48002510S
• Device LOT Number: 17653973
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/10/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/26/2018 Patient Sequence Number: 1