MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51007004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82168866 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.

Event Description

A 7mm 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at nominal pressure after seven seconds, during post-dilatation of an unknown stent in the right superficial femoral artery (sfa).The saber was therefore removed from the patient and replaced with a new balloon catheter, to complete the procedure.There was no patient injury.A contralateral approach was initially made, and a stent was implanted.The device will not be returned as it was discarded due to suspicion of infectious disease.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.A 7mm x 4cm x 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at nominal pressure after seven seconds during post-dilatation of an unknown stent in the right superficial femoral artery.It was removed from the patient and replaced with a new balloon catheter to complete the procedure.There was no patient injury.A contralateral approach was initially made, and a stent was implanted.Additional procedural details were requested but are unknown.The product was not returned for analysis as the device was discarded due to suspicion of infectious disease.A product history record (phr) review of lot 82168866 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 could not be determined.With the information available and without return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors such as post-stent dilation may have contributed to the reported event.The stent struts can easily damage balloon material if caution is not met when attempting to cross inside the stent.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER RX7MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9504038
• MDR Text Key: 199694608
• Report Number: 9616099-2019-03422
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032081808
• UDI-Public: 20705032081808
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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: 04/30/2022
• Device Catalogue Number: 51007004L
• Device Lot Number: 82168866
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1