MAUDE Adverse Event Report: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reex3528 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "attempted to place an 18 g 10 cm powerglide catheter into right basilic.Tip visualized in center of vein by rn.Flash was observed in catheter.Guidewire advanced without issue.Catheter slid over guidewire and was hubbed at the insertion site.The needle then was attempted to be pulled back and slid out about a quarter of the way and then was met with resistance.I immediately stopped and asked for assistance.She was holding the pts arm in place.I used one hand to hold her arm up while she looked at the device.She attempted to fold back the green wings from the hub of catheter to see if it was stuck in the hub and the patient had a muscle spasm, she then felt a slight ¿pop¿.She immediately put pressure just above the insertion site and i put pressure above the tourniquet and the er dr was called to the bedside.X-ray and surgery were then paged.While getting x-rays the patient had another muscle spasm and pushed the needle and guidewire mostly out of her body.That is when i saw that most of the catheter had been sheared off.We immediately called the dr.Back to bedside.We got the ok to remove the rest of the device since it was just barley inside the patient¿s arm.Guidewire was measured and found to be intact.Opened an extra powerglide to compare with.It was found that 2.5 cm of catheter was still attached to the hub and 7.5 cm was still missing.Surgery was looking at x-rays and found remaining catheter inside the patient¿s arm proximal to where pressure was placed.Decision was made to take patient to surgery for cut down and removal of catheter." add info rcvd 08/04/2021: was there patient harm reported?:yes.Surgical intervention required to remove broken catheter piece.What they¿re being treated for: acute and chronic respiratory failure, unspecified whether with hypoxia or hypercapnia.Patient requiring icu admission.Patient has a history of difficult iv access.While in the or, surgeons also had difficulty placing subclavian port, requiring multiple attempts.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the powerglide pro catheter being ¿sheared off¿ was confirmed.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The catheter was received detached from the assembly.The catheter exhibited a complete break 2.8cm from the molded joint.Abundant curved shape memory was observed throughout the distal fragment.Microscopic inspection of the break in the catheter revealed a partially glossy and partially granular fracture site.Inspection of the catheter tip revealed deformation.The guidewire was confirmed to be intact.Misaligned coils were observed near the weld tip.The catheter tip deformation and guidewire damage were consistent with attempted advancement, such as into tissue.The catheter curved shape memory was consistent with attempted catheter withdrawal against resistance, such as at a sharp angle.The break in the catheter was consistent with damage initiated by contact with the tip of the introducer needle.It appeared that initial advancement was attempted against resistance, possibly at a sharp insertion angle/into tissue, and subsequent attempts to withdraw the catheter caused the observed fracture and catheter compression.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.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.¿ h3 other text : evaluation findings are in section h.11.

Event Description

It was reported "attempted to place an 18 g 10 cm powerglide catheter into right basilic.Tip visualized in center of vein by rn.Flash was observed in catheter.Guidewire advanced without issue.Catheter slid over guidewire and was hubbed at the insertion site.The needle then was attempted to be pulled back and slid out about a quarter of the way and then was met with resistance.I immediately stopped and asked for assistance.She was holding the pts arm in place.I used one hand to hold her arm up while she looked at the device.She attempted to fold back the green wings from the hub of catheter to see if it was stuck in the hub and the patient had a muscle spasm, she then felt a slight ¿pop¿.She immediately put pressure just above the insertion site and i put pressure above the tourniquet and the er dr was called to the bedside.X-ray and surgery were then paged.While getting x-rays the patient had another muscle spasm and pushed the needle and guidewire mostly out of her body.That is when i saw that most of the catheter had been sheared off.We immediately called the dr.Back to bedside.We got the ok to remove the rest of the device since it was just barley inside the patient¿s arm.Guidewire was measured and found to be intact.Opened an extra powerglide to compare with.It was found that 2.5 cm of catheter was still attached to the hub and 7.5 cm was still missing.Surgery was looking at x-rays and found remaining catheter inside the patient¿s arm proximal to where pressure was placed.Decision was made to take patient to surgery for cut down and removal of catheter." add info rcvd 08/04/2021: was there patient harm reported?:yes.Surgical intervention required to remove broken catheter piece.What they¿re being treated for: acute and chronic respiratory failure, unspecified whether with hypoxia or hypercapnia.Patient requiring icu admission.Patient has a history of difficult iv access.While in the or, surgeons also had difficulty placing subclavian port, requiring multiple attempts.

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12374015
• MDR Text Key: 268351635
• Report Number: 3006260740-2021-03551
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REEX3528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 43