MAUDE Adverse Event Report: CORDIS CASHEL PTA SAVVY 3.00 X 2CM 150CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 435302X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been returned.However, the product analysis will be submitted within 30 days upon receipt.A device history record (dhr) review of lot 17529633 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, the pta savvy (3.00 x 2cm 150cm) balloon had a hole during balloon prep.There was no reported patient injury.The product was not clinically used and will be returned for analysis.The product was stored, handled, inspected and prepped according to the ifu.There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted.The procedure was successfully completed.

Manufacturer Narrative

Complaint conclusion: as reported, the 3x20mm 150cm savvy percutaneous transluminal angioplasty (pta) catheter balloon had a hole during balloon prep.The procedure was successfully completed.There was no reported patient injury.The product was stored, handled, inspected and prepped according to the ifu.There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted.A non-sterile pta savvy 3.00 x 2cm 150cm was received coiled inside of a clear plastic bag.The product was remove from the plastic bag to do a visual inspection without any optical magnifying device.The balloon was received with no inflation.No damages or anomalies were observed at the balloon or at the rest of device.A functional test was performed.The inflator/deflator device was attached to the hub.The balloon leakage test was done applying pressure with the inflator/deflator device to reach the nominal pressure.The balloon did not get inflated as expected due to a leakage condition that was detected.Sem results found that the leakage was caused by a rupture found on the savvy catheter body.The rupture presented a ripped material condition and material elongation, also scratches were observed around the ruptured area.These conditions observed could be related to an unknown object that could induce the rupture of the body and cause the scratch conditions observed.There were no other anomalies found.A device history record (dhr) review of lot 17529633 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was not confirmed through analysis of the returned device.However, a leakage/rupture was noted in the balloon catheter body.The exact cause of the body/shaft leakage experienced by the customer could not be conclusively determined during the analysis.Based on the limited information available for review, concomitant device factors and handling factors likely contributed to the leakage/rupture experienced as evidenced by the scratches and material elongation noted during sem analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PTA SAVVY 3.00 X 2CM 150CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7318782
• MDR Text Key: 101860425
• Report Number: 9616099-2018-01965
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 435302X
• Device Catalogue Number: 435302X
• Device Lot Number: 17529633
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1