MAUDE Adverse Event Report: CORDIS CASHEL SABER RX25MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51002504L

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the saber rx balloon catheter tip was separated in two pieces before it was put in the patient. The procedure was completed with a non cordis balloon. There was no patient injury. The saber rx balloon catheter was placed over the guidewire and before the balloon entered the sheath, the tip of the balloon catheter was broken in two parts. The product was inspected prior to use and appear to be normal. The product prepped properly according to the instruction for use (ifu) with no problems noted during prepping. One non-sterile saber rx 2. 5mm4cm155cm was received for analysis coiled inside a plastic bag. Per visual analysis, the tip of the balloon catheter was observed separated /damaged (the separated piece was not returned for analysis). No other anomalies observed. The separation of the catheter distal tip was observed under vision system and tip presented elongations and frayed edges. These characteristics presented evidence of application of a tension/force that induced the separation. No other issues were noted. A device history record (dhr) review of lot 17334360 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¿ was confirmed through analysis of the returned device. However, the exact cause of the separation could not be conclusively determined during analysis. Based on the limited information available for review, handling factors may have contributed to the issue reported as evidenced by presence of elongations and frayed edges at the separation site. The ifu has been reviewed, and it states that separation of a device component is a potential complication. According to the instructions for use ¿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 review nor the product analysis suggests that the event experienced by the customer could be related to the design or manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

It was reported that the saber rx balloon catheter tip was separated in two pieces before it was put in the patient. The procedure was completed with a non cordis balloon. There was no patient injury. The saber rx balloon catheter was placed over the guidewire and before the balloon entered the sheath, the tip of the balloon catheter was broken in two parts. The product was inspected prior to use and appear to be normal. The product prepped properly according to the instruction for use (ifu) with no problems noted during prepping.

• Brand Name: SABER RX25MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tp ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tp ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6610855
• MDR Text Key: 76719980
• Report Number: 9616099-2017-01143
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2018
• Device Model Number: 51002504L
• Device Catalogue Number: 51002504L
• Device Lot Number: 17334360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 05/10/2017
• Event Location: No Information
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial