MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX4MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51004015L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the balloon of a saber rx 4mm 15cm 155 ruptured after passing the nominal pressure 8 atm, it ruptured at approximately 10 to 12 atm; therefore, it was replaced with a new saberx (4mm*10cm) and it could be inflated 14 atm and the case was completed. There was no reported injury to the patient. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the device from the hoop. There was no difficulty noted while removing the protective balloon cover, stylet, or any of the sterile packaging components. There were no kinks or other damages noted on the device prior to inserting into the patient. The device was prepped per the ifu and was able to maintain negative pressure. The lesion was the left superficial femoral artery, popliteal artery to back-knee with stenosis and occlusion. An approach was made from the right femoral artery with a non-cordis 6f guiding sheath. A non-cordis. 018 guidewire crossed the lesion. The lesion was noted to have moderate to severe calcification. The vessel had moderate tortuosity. The lesion had a 80%-100% stenosis. The device was being used to treat a chronic total occlusion (cto). A saberx (3mm*4cm) was inflated at the superficial femoral artery to the popliteal artery. After that, the saber rx 4mm 15cm 155 was used. It crossed the lesion and inflated the ruptured. The non-cordis inflation device was filled with visipaque. The contrast/saline ratio was unknown. The inflation device was used successfully with other devices during the case. A y-connector was used for inserting the balloon catheter. The balloon catheter was never in an acute bend and was never kinked while being used. The device was removed without any issues. The device was discarded and will not be returned.

• Brand Name: SABER RX4MM15CM155
• 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: 13953922
• MDR Text Key: 290462596
• Report Number: 9616099-2022-05493
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 51004015L
• Device Catalogue Number: 51004015L
• Device Lot Number: 82230538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/30/2022 Patient Sequence Number: 1

Treatment

GUIDEWIRE (0.018 VASSALLO, ASAHIINTECC); INFLATION DEVICE: GM30, NIPRO; PARENT GUIDING SHEATH (6F); SABERX (3MM*4CM), SABERX (4MM*10CM)