MAUDE Adverse Event Report: CORDIS CASHEL SABER RX8MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51008004L

Device Problems Detachment Of Device Component (1104); Crack (1135); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

It was reported that the saber balloon catheter was inserted, however, the balloon catheter was caught by the calcification and could not cross the lesion.Once the saber balloon was removed from the patient, it was confirmed that the tip was fractured.The saber balloon was replaced with another unknown balloon and the procedure was completed successfully.There was no patient injury.The target lesion was the iliac artery.The patient¿s vessel level of tortuosity was unknown.The lesion was calcified.The rate of stenosis was unknown.The product was clinically used and will be returned for analysis.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received and after the device was evaluated the tip was separated and not received, the code will be changed to detachment of device component.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received from fal and a 29cm rupture was observed on the outer body of the guide wire lumen section and an 8cm section of the distal core wire was exposed and the tip was partially separated.Therefore malfunction code distal tip - separated was removed and distal tip - cracked in patient was added and malfunction code body/shaft - burst was added.(b)(4).

Manufacturer Narrative

It was reported that during use, the saber rx8mm4cm155 balloon catheter failed to cross the target lesion, was cracked in-patient and the shaft burst.The saber was inserted; however, the balloon catheter was caught by the calcification in the vessel/target lesion and could not cross the lesion.Once the saber balloon was removed from the patient, it was confirmed that the tip was fractured.The saber balloon was replaced with another unknown balloon and the procedure was completed successfully.There was no patient injury.The target lesion was the iliac artery.The patient¿s vessel level of tortuosity was moderate.The lesion was moderately calcified.The rate of stenosis was ninety percent (90%).No other information was provided.Additional information was received from fal and the tip was partially separated.One non-sterile unit of saber rx8mm4cm155 was received coiled inside a plastic.Per visual analysis the balloon was previously inflated/deflated, the distal tip of the balloon device was received partially separated; also, a 29cm rupture was observed on the outer body of the guide wire lumen section and an 8cm section of the distal core wire was exposed.Blood residuals were observed in the balloon and in the inflation section, this might be secondary to the rupture observed on the outer body of the wire lumen section.No other damages were noted in the device.The rupture observed on the outer body of the guide wire lumen section was examined under microscope and it was observed that the edges presented plastic deformation and stretched conditions; thus, these indicate that the outer body material was submitted to a pulling\stretched force before it got ruptured.The separated tip was inspected under microscope and it was noticed that the separated edges present evidence of elongation.Unit was sent to sem analysis to identify the potential cause of the tip separated the following results: ¿results showed that the separated tip presented evidence of plastic deformation such as elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling events that exceeds the material yield strength prior to the separation.No other issues were noted during sem analysis¿.Review of lot 17449264 revealed no anomalies during the manufacturing and inspection processes.The complaint reported as ¿distal tip - cracked - in-patient¿ was confirmed as the product was received.The root cause of the saber tip fractured\separated as well as the rupture observed on the outer body of the guide wire lumen section could not be conclusively determined.However, the failure ¿body/shaft~ burst reported by the customer was not confirmed however, the outer body ruptured was noted during analysis, the exact cause of this failure could not be conclusively determined.However, neither dhr review results nor product analysis results suggests that they may be related to the manufacturing process; however, sem results suggested that procedural\handling factors might have contributed to both events.Therefore, no corrective or preventive actions will be taken at this time.Per 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.¿ based on the information available for review, vessel characteristics (90% stenosis, moderately calcified and tortuous) may have contributed to the damage to the device as noted during analysis.Neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX8MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7005798
• MDR Text Key: 92493095
• Report Number: 9616099-2017-01557
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 51008004L
• Device Catalogue Number: 51008004L
• Device Lot Number: 17449264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/11/2017
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 12/08/2017; 01/08/2018; 01/25/2018
• Supplement Dates FDA Received: 11/22/2017; 01/02/2018; 01/19/2018; 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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