MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48004015X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2019

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

Event Description

It was reported that the tip of a saber balloon catheter (4mm, 15cm, 150) fell off during prep.The device was not clinically used and there was no reported patient injury.The product was opened in a sterile field and stored as per labeling.The device was not used in the patient.There were no anomalies noted to the device when it was taken out of the packaging.The product was prepped properly according to the ifu.The device did not prep normally; the tip fell off when injecting saline.The device did not kink in the area of separation.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: the tip of a saber balloon catheter (4mm x 15cm x 150cm) fell off during prep.The device was not clinically used and there was no reported patient injury.The product was opened in a sterile field and stored as per labeling.The device was not used in the patient.There were no anomalies noted to the device when it was taken out of the packaging.The product was prepped properly according to the ifu.The device did not prep normally; the tip fell off when injecting saline.The device did not kink in the area of separation.One product was returned for analysis.A non-sterile saber 4mm x 15cm x 150cm was returned.Per visual analysis the balloon catheter was coiled inside of a clear plastic bag with the balloon deflated.A separation was noted at the distal tip.No other damages or anomalies were observed on the returned product.Per sem analysis, the saber tip separation was observed on pictures.The soft tip (blue tip) that separated, was not received for analysis.Results showed that the analyzed section of the mating sites, where the soft tip is fused to the balloon and inner body, presented evidence of elongations.The elongations suggest that the tip was induced to stretching/pulling events that exceeded the tip material yield strength prior to the separation.No other issues were noted during sem analysis.A product history record (phr) review of lot 17685990 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 during prep¿ was confirmed through analysis of the returned device.The exact cause of the separation could not be conclusively determined.However, analysis revealed elongations suggesting the tip was induced to stretching/pulling events that exceeded the tips material yield strength prior to the separation.Therefore, procedural or handling factors may have contributed to the reported event.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 review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 4MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8348349
• MDR Text Key: 140003134
• Report Number: 9616099-2019-02727
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069486
• UDI-Public: 20705032069486
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 48004015X
• Device Catalogue Number: 48004015X
• Device Lot Number: 17685990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1