MAUDE Adverse Event Report: CORDIS CASHEL SABER RX2MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51002030L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17680249) 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

As reported, a saber rx pta (2mm30cm155) balloon catheter was inserted to the patient and the physician checked under the angiography.However, the proximal marker position was confirmed not to be in the normal position.There was no reported patient injury.The procedure was completed successfully.The saber pta balloon catheter (complaint product) was used for an endovascular repair (evt) case.The devices will be returned for analysis.

Manufacturer Narrative

As reported, a 2x300 155cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter was inserted to the patient, and the physician checked under the angiography.However, the proximal marker position was confirmed not to be in the normal position.The procedure was completed successfully.There was no reported patient injury.The saber pta balloon catheter was used for an endovascular repair (evt) case.A non-sterile saber rx2mm30cm155 was received coiled inside a plastic bag.Per visual analysis, the balloon seems to have been inflated and deflated.Also, dried blood residues were observed on the unit.The marker bands were inspected, and no damages or anomalies could be observed.A dimensional analysis was performed to verify the correct distance between the distal and the proximal marker bands.The measurement was compared against the specification and the result was found within specification.A device history record (dhr) review of lot 17680249 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band offset/out of position in patient¿ was not be confirmed since the marker bands were found to be within specification.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the instructions for use, which is not intended as a mitigation, ¿radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ neither the dhr review, nor the product analysis suggests that the reported issue could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: SABER RX2MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7738597
• MDR Text Key: 115671896
• Report Number: 9616099-2018-02277
• Device Sequence Number: 1
• Product Code: LIT
• 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: 08/29/2018

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: 05/31/2020
• Device Catalogue Number: 51002030L
• Device Lot Number: 17680249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1