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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 4MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 4MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48004020X
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, after inserting a saber balloon catheter (4mm20cm 150) into the patient the balloon ruptured as soon as it was inflated. There was no patient injury reported. The device was clinically used and will be returned for analysis. The device was stored and prepped per the ifu. The product looked normal when removed from its packaging. The device prepped normally. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. No kinks or other damages were noted prior to inserting the product into the patient. The target site was described as not calcified or tortuous with 80% stenosis. The contrast media being used was a non-cordis product. The contrast to saline ratio was 1:1. The inflation device was a cordis inflation device((b)(4)). The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. The device was not used for a chronic total occlusion (total occlusion >3 months). The device did not have to pass through a previously placed stent. The balloon was inflated only once. The maximum inflation pressure was eight atmospheres (atms). No leakage was noted from the device. The product was removed intact from the patient. No other anomalies were noted when the device was removed from the patient. The procedure was completed using another product.
 
Manufacturer Narrative
As reported, after inserting a 4x200mm 150cm saber balloon catheter (bc) into the patient the balloon ruptured as soon as it was inflated. There was no patient injury reported. The device was stored and prepped per the ifu. The product looked normal when removed from its packaging. The device prepped normally. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. No kinks or other damages were noted prior to inserting the product into the patient. The target site was described as not calcified or tortuous with 80% stenosis. The contrast media being used was a non-cordis product. The contrast to saline ratio was 1:1. The inflation device was a cordis inflation device. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. The device was not used for a chronic total occlusion (total occlusion >3 months). The device did not have to pass through a previously placed stent. The balloon was inflated only once. The maximum inflation pressure was eight atmospheres (atms). No leakage was noted from the device. The product was removed intact from the patient. No other anomalies were noted when the device was removed from the patient. The procedure was completed using another product. One non-sterile unit of a saber 4mm20cm 150 balloon catheter was received for analysis coiled inside a plastic bag. Per visual analysis, the balloon of the saber was observed as have not been previously inflated. Dried blood residues could be observed on the balloon of the unit. Also, a cracked condition was observed on the hub of the unit received. The hub of the unit was reviewed under the fal vision system to inspect for any tool marks that could have caused the crack condition; none was observed. No other anomalies found. Balloon leak test was attempted to be performed with no success. Water was applied to the inflation lumen of catheter using a lab sample syringe and the liquid could not flow through the inflation lumen up to the balloon due to a leakage in the hub of the saber because of the cracked condition present in the hub. The unit was sent to sem analysis to determine the root cause of the hub crack. Sem analysis results showed that the crack passed through the wall thickness of the hub. Transversal view of the fractured section of the hub showed a fracture pattern that presents evidence of plastic deformations along of the fractured surfaces of the hub, commonly found on tensile fractured surfaces. No other anomalies were found during sem analysis. A device history record (dhr) review could not be conducted as the lot number provided does not match the device reported and received. The reported ¿balloon burst at/below rbp¿ could not confirmed through analysis of the returned device since the balloon leak test could not be successfully performed. However, a leakage in the hub of the saber was noted due to a cracked condition found in the hub. However, the cause of the hub crack and the stress on the material that yielded to the crack found on the hub could not be conclusively determined during analysis. Based on the limited information available for review, it is possible that handling factors contributed to the hub crack found as evidenced by the plastic deformations noted at the fractured surfaces. The plastic deformations found on the hub suggests that the hub was induced to an excess of force (tension) that caused the cracking on the hub. According to the instructions for use (ifu), which is not intended as a mitigation, ¿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. Do not use if product damage is suspected or evident. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. 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. ¿ neither the product analysis nor the dhr review suggests that the event reported could be related to the manufacturing process. Therefore, no corrective/preventive actions will be taken at this time.
 
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Brand NameSABER 4MM20CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
MDR Report Key7798780
MDR Text Key117836726
Report Number9616099-2018-02327
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model Number48004020X
Device Catalogue Number48004020X
Device Lot Number17687253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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