MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number UNKNOWN

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

Patient Problem Death (1802)

Event Date 03/11/2018

Event Type  Death  

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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the emergency room (er) service tech was attempting to place a powerglide in a critical patient in the emergency department.He stated that he got the device into the vein and went to deploy the guidewire and the purple switch would not move/would not advance.He stated he tried repositioning the device and the same thing happened, so he pulled the device out, but couldn't get the guidewire out.He stated that the catheter came off the needle and there was not guidewire on the end of the device.He stated that while the device was in the patient's arm, the purple switch never moved, he tried again at a different angle and it never advanced, he stated that the guidewire did not deploy.He stated that the guidewire would not advance/didn't move.He said that x-ray was in the room at the time, but approximately five minutes later the patient coded, was resuscitated and then passed away.

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 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 that the guidewire would not advance was confirmed, but the root cause is unknown.One 18g x 10cm powerglide flex catheter and deployment system were returned for investigation.Evidence of use was observed on the returned sample.The catheter had been removed from the needle and the catheter wings remained attached to the catheter.The safety mechanism was activated and locked in place over the needle tip.Red colored residue remained within the catheter and safety mechanism.The guidewire push-off button was in the retracted position.The guidewire was observed within the housing, but was not attached to the coupler.No defects were noted on the coupler.What caused the guidewire to detach from the coupler was unknown, but this can occur if the guidewire push-off button was advanced while the guidewire was constrained in the needle and tissue.It was reported that the purple guidewire push-off button would not move/advance after insertion, which indicates that the guidewire may have met resistance during use.Without the wire attached to the coupler, the wire could not be advanced through the needle.The guidewire was complete, intact, and secured to the deployment system.After reassembling the guidewire to the coupler, a functional test revealed that the guidewire could be moved in and out of the needle with the push-off button.A red colored biological residue was observed on the distal tip of the guidewire.Due to the condition of the returned product, it is possible that the guidewire detached from the coupler during use.It was reported that the patient coded soon after the procedure.It could not be confirmed that the device caused or contributed to the reported death.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the er service tech was attempting to place a powerglide in a critical patient in the emergency department.He stated that he got the device into the vein and went to deploy the guidewire and the purple switch would not move/would not advance.He stated he tried repositioning the device and the same thing happened, so he pulled the device out, but couldn't get the guidewire out.He stated that the catheter came off the needle and there was not guidewire on the end of the device.He stated that while the device was in the patient's arm, the purple switch never moved, he tried again at a different angle and it never advanced, he stated that the guidewire did not deploy.He stated that the guidewire would not advance/didn't move.He said that x-ray was in the room at the time, but approximately five minutes later the patient coded, was resuscitated and then passed away.

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.Additional event details received on 05/09/2018.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 that the guidewire would not advance was confirmed, but the root cause is unknown.One 18g x 10 cm powerglide flex catheter and deployment system were returned for investigation.Evidence of use was observed on the returned sample.The catheter had been removed from the needle and the catheter wings remained attached to the catheter.The safety mechanism was activated and locked in place over the needle tip.Red colored residue remained within the catheter and safety mechanism.The guidewire push-off button was in the retracted position.The guidewire was observed within the housing, but was not attached to the coupler.No defects were noted on the coupler.What caused the guidewire to detach from the coupler was unknown, but this can occur if the guidewire push-off button was advanced while the guidewire was constrained in the needle and tissue.It was reported that the purple guidewire push-off button would not move/advance after insertion, which indicates that the guidewire may have met resistance during use.Without the wire attached to the coupler, the wire could not be advanced through the needle.The guidewire was complete, intact, and secured to the deployment system.After reassembling the guidewire to the coupler, a functional test revealed that the guidewire could be moved in and out of the needle with the push-off button.A red colored biological residue was observed on the distal tip of the guidewire.Due to the condition of the returned product, it is possible that the guidewire detached from the coupler during use.It was reported that the patient coded soon after the procedure.It could not be confirmed that the device caused or contributed to the reported death.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the er service tech was attempting to place a powerglide in a critical patient in the emergency department.He stated that he got the device into the vein and went to deploy the guidewire and the purple switch would not move/would not advance.He stated he tried repositioning the device and the same thing happened, so he pulled the device out, but couldn't get the guidewire out.He stated that the catheter came off the needle and there was not guidewire on the end of the device.He stated that while the device was in the patient's arm, the purple switch never moved, he tried again at a different angle and it never advanced, he stated that the guidewire did not deploy.He stated that the guidewire would not advance/didn't move.He said that x-ray was in the room at the time, but approximately five minutes later the patient coded, was resuscitated and then passed away.Additional details: patient is diabetic, hypertension, respiratory disorder.Per patient safety officer the cause of death was not due to guidewire not moving or advancing.At the time the patient coded an iv central line was placed for fluids to be administered while patient was in emergency decomposition.

• Brand Name: POWERGLIDE MIDLINE CATHETER
• Type of Device: CATHETER,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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7396146
• MDR Text Key: 104354189
• Report Number: 3006260740-2018-00585
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death