Catalog Number 4400804X |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not yet been returned for analysis, and the engineering evaluation has not yet been completed.Additional information will be submitted within 30 days of receipt.
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Event Description
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It was reported that the distal tip of the balloon of the 8.0x4.0mm 135cm powerflex pro device separated in the patient.There was no report of patient injury.They used a snare device in order to remove the distal tip from the patient.No product information is known at this time.The target lesion was the iliac anastomosis.They used a brachial approach.After inflating the balloon, the balloon was fully deflated and they began to take it out of the patient.At that point, the scrub tech noticed that the catheter was starting to stretch.She told the doctor and ceased the removing of the balloon.At that point, the physician moved the balloon forward in an effort to dislodge it from any calcium that it may have been caught on.At that point, they continued to take it out of the patient, but they took the sheath out with it, while keeping the wire where it was.After everything came out of the patient, they realized that the distal end of the balloon was still inside the patient.At that point, the physician asked for another physician to assist with a snare device in order to take the distal tip out of the patient.No further issues at that time and the physician determined that would be the end of the case.The device will be returned for analysis.
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Manufacturer Narrative
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The device was returned for analysis, however the engineering evaluation has not yet been completed.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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The distal tip of the balloon of the 8.0x4.0mm 135cm powerflex pro balloon catheter (bc) separated in the patient.There was no report of patient injury.They used a snare device in order to remove the distal tip from the patient.No product information is known at this time.The target lesion was the iliac anastomosis.They used a brachial approach.After inflating the balloon, the balloon was fully deflated and they began to take it out of the patient.At that point, the scrub tech noticed that the catheter was starting to stretch.She told the doctor and ceased the removing of the balloon.At that point, the physician moved the balloon forward in an effort to dislodge it from any calcium that it may have been caught on.At that point, they continued to take it out of the patient, but they took the sheath out with it, while keeping the wire where it was.After everything came out of the patient, they realized that the distal end of the balloon was still inside the patient.At that point, the physician asked for another physician to assist with a snare device in order to take the distal tip out of the patient.No further issues at that time and the physician determined that would be the end of the case.The device will be returned for analysis.One non-sterile unit of unknown powerflex pro was returned.The balloon was received burst and the distal section of the balloon along including the distal tip were separated and were not returned.Blood traces were observed on the proximal section of the balloon.No other damage was observed on the device.Functional analysis was not performed due to condition of the balloon.Per sem analysis results showed that the balloon external and internal surface exhibited no evidence of damages near to the edge of the separation.The inner body showed evidence of elongations; this characteristic suggests possible stretching/ pulling until separation.As no product lot number was provided no device history records (dhr) review could be performed.The reported ¿distal tip - separated-in patient (peripheral)¿ was confirmed through analysis of the returned device.The exact cause of the separation could not be determined during analysis.Based on the information available for review, vessel characteristics are unknown.The elongations observed on the inner body suggest the use of excessive force resulting in stretching of the device.According to the instructions for use ¿caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ 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.
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Search Alerts/Recalls
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