MAUDE Adverse Event Report: CORDIS CASHEL SABER 3.5MM6CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003506X

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/11/2017

Event Type  malfunction  

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

Event Description

As reported, a saber balloon catheter (3.5mm6cm 150) was found to have a hole in the middle third of the shaft distal from the catheter that would not allow the balloon to be inflated.Another balloon was opened to continue the procedure.There was no patient injury reported.The device will be returned for analysis.Multiple attempts to gather additional information have been made and have been unsuccessful.

Manufacturer Narrative

Complaint conclusion: this is an updated complaint conclusion due to product analysis received march 27th, 2019.A saber balloon catheter (3.5mm x 6cm x 150cm) was found to have a hole in the middle third of the shaft distal from the catheter that would not allow the balloon to be inflated.Another balloon was opened to continue the procedure.There was no patient injury reported.One product was returned for analysis.A non-sterile saber 3.5mm x 6cm x 150cm balloon catheter was returned.Per visual analysis the balloon catheter was coiled inside a plastic bag, dried blood residues and dried saline solution residues were observed.No other anomalies could be observed.Per sem analysis a hole was noted on the outer body of the catheter at 10 cm from the distal tip, this was caused by a cut on the outer body.The cut was caused by an unknown sharp object.The external surface of the outer body presented evidence which indicates that the first contact of the sharp object was on the external surface, also the compressed material on the opposite side indicates a cutting path direction.This type of damage is commonly caused during the interaction of the outer body material with a sharp object or mechanical damage.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 17623961 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft-puncture/cut¿ was confirmed due to the hole/cut observed on the unit.However, the exact cause of the damage could not be determined during analysis.Sem analysis revealed the surface of the catheter encountered a sharp object or mechanical damage.It is very likely that vessel characteristics; although unknown, may have contributed to the reported event.A highly calcified vessel can damage the catheter when attempting to cross a lesion.According to the safety information in 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 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 3.5MM6CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8382685
• MDR Text Key: 137935934
• Report Number: 9616099-2019-02762
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069356
• UDI-Public: 20705032069356
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 48003506X
• Device Catalogue Number: 48003506X
• Device Lot Number: 17623961
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1