MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005010L

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17605007) 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.

Event Description

As reported, a saber rx pta balloon catheter (5 mm 15 cm 155) was delivered to the lesion and inflated as a pre dilatation.Then, it was delivered again for a post dilatation.However, the distal tip was confirmed to have been come off.The saber rx pta balloon catheter was removed from the patient and the distal tip was fixed.After this, a different size new balloon catheter completed the procedure.The procedure was completed successfully.There was no reported patient injury.The target lesion was the iliac artery.The lesion was heavily calcified.The patient¿s vessel level of tortuousness was unknown.The rate of stenosis was unknown.Initially, there were no anomalies confirmed on the device before and during use.The tip was on the guidewire, and both were removed together from the patient.The separated distal tip will be returned for analysis with the complaint product.As of note: ¿the physician commented that the reason of this issue seemed to be due to heavy calcification¿.

Manufacturer Narrative

As reported, a 5x150mm 155cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated for pre-dilatation.However, it was delivered again for a post ¿dilatation, and the distal tip was confirmed to have come off.The saber rx pta balloon catheter was removed from the patient and the distal tip was fixed.After this, a different size new balloon catheter completed the procedure.The procedure was completed successfully.There was no reported patient injury.The target lesion was the iliac artery.The lesion was heavily calcified.The patient¿s vessel level of tortuousness was unknown.The rate of stenosis was unknown.Initially, there were no anomalies confirmed on the device before and during use.The tip was on the guidewire, and both were removed together from the patient.The separated distal tip will be returned for analysis with the complaint product.As of note: ¿the physician commented that the reason of this issue seemed to be due to heavy calcification¿.The device was not returned for analysis.A device history record (dhr) review of lot 17605007 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information provided, vessel characteristics (crossing a heavily calcified lesion) and procedural/handling factors may have contributed to the reported event.According to the instructions for use (ifu), ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER RX5MM10CM155
• 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
• MDR Report Key: 7206271
• MDR Text Key: 98069900
• Report Number: 9616099-2018-01794
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 51005010L
• Device Lot Number: 17605007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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