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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F120101
Device Problems Material Fragmentation (1261); Physical Resistance (2578)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter was confirmed and the damage appeared to be use related. One 20ga x 10cm powerglide catheter and deployment system were returned for investigation. The catheter was received attached to the deployment system. The returned sample revealed evidence of use. Blood residue was observed within the catheter. The guidewire had been advanced through the needle, but the wire was no longer attached to the coupler on the guidewire button slider. A 1cm section of guidewire was unraveled just distal to the needle. A break in the core wire was observed 3. 4cm from the distal tip of the guidewire. A microscopic examination revealed that the weld tip was present at the distal tip of the guidewire. The catheter tubing extended 7. 2cm from the distal end of the pink strain relief sleeve, which indicates that approximately 2. 8cm of the catheter was missing. The distal end of the catheter was not returned for investigation. A microscopic examination of the catheter revealed a longitudinal slit in the distal end of the catheter segment, which is consistent with a needle puncture. The section of catheter around the longitudinal split exhibited a smooth and glossy surface. It appears that the needle punctured through the side of the catheter, which most likely initiated a complete breach in the catheter tubing. The product ifu warns, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle. This may result in damage to the catheter. If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter. ¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure. ¿ the observed damage and reported complications appear to be related to use of the device. A lot history review (lhr) of rebx0132 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during placement, the powerglide pro got blood return so they advanced the catheter. They felt resistance and decided to retract the guidewire and pulled the entire device out. After they had removed the device they noticed half of the catheter was missing. Vascular surgery found the catheter in the tissue of the patient, at that time the decision was made not to remove the piece of catheter.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebx0132 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during placement, the powerglide pro got blood return so they advanced the catheter. They felt resistance and decided to retract the guidewire and pulled the entire device out. After they had removed the device they noticed half of the catheter was missing. Vascular surgery found the catheter in the tissue of the patient, at that time the decision was made not to remove the piece of catheter.
 
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Brand NameDOT PG PRO 20G 10CM FULL
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7162778
MDR Text Key192871903
Report Number3006260740-2017-02365
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF120101
Device Catalogue NumberF120101
Device Lot NumberREBX0132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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