MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis cashel are respectively, (b)(4).(b)(6).The device was returned but the engineering report is pending.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 the saber device in this report is not sold in the us but is similar to other cordis pta catheters that are sold in the us.

Event Description

A 7mm4cm155 saber percutaneous transluminal angioplasty (pta) catheter ruptured at 4 atmospheres (atm) during its initial inflation.There was no patient injury and the device will be returned for analysis.The lesion was the iliac artery.A guidewire crossed the lesion and the saber pta was delivered to the lesion.

Manufacturer Narrative

A 7x40mm 155cm saber rx percutaneous transluminal angioplasty (pta) catheter ruptured at four (4) atmospheres (atm) during its initial inflation.There was no patient injury.The lesion was the iliac artery.A guidewire crossed the lesion and the saber pta was delivered to the lesion.The device was not returned for analysis.A device history record (dhr) review of lot 17337641 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst at/below rbp¿ 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 (although not provided) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.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 review 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 RX7MM4CM155
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 7885954
• MDR Text Key: 120702266
• Report Number: 9616099-2018-02397
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 51007004L
• Device Lot Number: 17337641
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1