MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM25CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was not returned for analysis.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.Please note that this device is not sold in the united states, however, it is similar to other cordis pta catheters that are sold in the u.S in the lit device family.

Event Description

During post-dilatation of a lesion with a 5mm25cm155 saber rx percutaneous transluminal angioplasty (pta) catheter, it ruptured at the distal portion of the lesion.Therefore, it was replaced with a new balloon catheter (6mmx25cm) and the lesion was inflated.The device has been discarded in the hospital.There was no patient injury reported.The lesion was the right superficial femoral artery which had unspecified stenosis.The vessel was calcified.An approach was made from the right inguinal region.A guidewire (0.014) crossed the lesion and a cutting balloon catheter (6mmx2cm) was inserted and inflated as pta.A drug-coated balloon (6mmx15cm) was inserted and inflated.Then the saber was inserted.Hemostasis was achieved, and the procedure was completed.The physician commented that it was unclear that balloon rupture was occurred if there was malfunction of the device or the calcified vessel.

Manufacturer Narrative

During post-dilatation of a lesion with a 5x250mm 155cm saber rx percutaneous transluminal angioplasty (pta) catheter it ruptured at the distal portion of the lesion.Therefore, it was replaced with a new balloon catheter (6x250mm) and the lesion was inflated.Hemostasis was achieved, and the procedure was completed.There was no patient injury reported.The lesion was the right superficial femoral artery with 80% stenosis.The vessel was calcified.There was no vessel tortuosity.An approach was made from the right inguinal region.A guidewire (0.014) crossed the lesion and a cutting balloon catheter (6x20mm) was inserted and inflated as pta.A drug-coated balloon (6x150mm) was inserted and inflated.Then the saber was inserted.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The contrast used was visipaque injection 320/ daiichisankyo).The contrast to saline ratio was 1:3.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion.The catheter was never in an acute bend.It also did not kink while being used.The balloon was easily removed.Additional patient and procedural details were requested but were not available.The physician commented that it was unclear that balloon rupture was occurred if there was malfunction of the device or the calcified vessel.The device was not returned for analysis.A device history record (dhr) review of lot 17620006 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause of the burst could not be determined.Based on the limited information available for review, vessel characteristics (calcified vessel that required a cutting balloon) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can damage the balloon.According to the information for safety in the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX5MM25CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 8174142
• MDR Text Key: 131385938
• Report Number: 9616099-2018-02591
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 51005025L
• Device Lot Number: 17620006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIRE (0.014)