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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT)

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CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 4400804X
Device Problems Detachment Of Device Component; Catheter; Tip
Event Date 11/02/2015
Event Type  Injury  
Manufacturer Narrative

(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.

 
Event Description

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.

 
Manufacturer Narrative

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.

 
Manufacturer Narrative

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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Brand NamePOWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
Type of DevicePTA CATHETERS (LIT)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua  32580
  32580
7863133880
MDR Report Key5238336
Report Number9616099-2015-00577
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number4400804X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/20/2015 Patient Sequence Number: 1
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