MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003004S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

This device has been tested and evaluated.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 90 cm.Saber 3 mm.X 4 cm.Balloon catheter tip was broken when the doctor pushed the wire through the catheter.Everything happened outside of the patient.Additional information has been received.There was no reported patient injury.There was no other product issue noted either at the account, after the procedure, or prior to shipping for inspection.The complaint occurred outside of the patient.The saber tip was broken off. there was no difficulty removing the product from the hoop, or any difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There was no resistance/friction while inserting the balloon through the guide catheter.There was no resistance/friction with other devices.

Manufacturer Narrative

Complaint conclusion: the 90 cm.Saber 3 mm.X 4 cm.Balloon catheter (bc) tip was broken when the doctor pushed the wire through the catheter.Everything happened outside of the patient.There was no reported patient injury.There was no other product issue noted either at the account, after the procedure, or prior to shipping for inspection.The complaint occurred outside of the patient.The saber tip was broken off.  there was no difficulty removing the product from the hoop, or any difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There was no resistance/friction while inserting the balloon through the guide catheter.There was no resistance/friction with other devices.The product was returned for analysis.One non-sterile unit of saber 3mm x 4cm 90cm bc was returned.Per visual analysis the balloon had not been inflated and the distal tip of the balloon device was found separated.No other damages were noted in the device.Per microscopic analysis the separated edges revealed evidence of elongation.Per sem analysis the distal and proximal sections of the rupture revealed evidence of elongations.The elongations suggest that the device was subjected to stretching or pulling events that exceeded the material yield strength of the device prior to the separation.No other issues were noted during sem analysis.A device history record (dhr) review of lot 17385337 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 event could not be determined during analysis.Based on the information available for review, handling factors may have contributed to the separation as evidenced by the elongations noted on the device during analysis indicative of excessive force being applied during removal of the balloon cover.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 manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER 3MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32580 ; MX 32580
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6188078
• MDR Text Key: 62802964
• Report Number: 9616099-2016-00799
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 48003004S
• Device Catalogue Number: 48003004S
• Device Lot Number: 17385337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/21/2016
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1