MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005010L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

As reported, during the post dilation and the 3rd inflation, the balloon of a saber rx 5mm 10cm ruptured while attempting to inflate.The case was completed after it was replaced with another balloon catheter (unknown).There was no reported injury to the patient.The lesion was the superficial femoral artery.A non-cordis guidewire crossed the lesion and the saber pta, it was used as pre-dilation.The balloon was inflated at 10 atm.A non-cordis stent was implanted.The saber was inserted again for post-dilation and the balloon was inflated to 14 atm twice.During the 3rd attempt to inflate, the balloon ruptured.The device will not be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82221962 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER RX5MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13724289
• MDR Text Key: 287129102
• Report Number: 9616099-2022-05440
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075982
• UDI-Public: (01)20705032075982(17)240531(10)82221962
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51005010L
• Device Catalogue Number: 51005010L
• Device Lot Number: 82221962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Date Device Manufactured: 06/03/2021
• 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
• Treatment: GUIDEWIRE (VASSALLO FLOPPY, FILMEC); STENT (ZILVERPTX); UNKNOWN BALLOON CATHETER