MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005015X

Device Problem Structural Problem (2506)

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

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the marker bands on a saber balloon catheter (5mm15cm 150) were out of position.There was no patient injury reported.The device was clinically used.

Manufacturer Narrative

Complaint conclusion: the marker bands on a saber balloon catheter (5mm x 15cm x 150cm) were out of position.There was no patient injury reported.The device was not returned for analysis.A product history record (phr) review of lot 82155820 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band-balloon catheters- offset/out of position-in patient¿ could not be confirmed as the device was not returned for analysis.Therefore, specification orientation of marker bands cannot be confirmed.The exact cause could not be determined.With the 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 device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ 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.

• Brand Name: SABER 5MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8406355
• MDR Text Key: 140153414
• Report Number: 9616099-2019-02773
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069189
• UDI-Public: 20705032069189
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 48005015X
• Device Catalogue Number: 48005015X
• Device Lot Number: 82155820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1