MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER; INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2017

Event Type  Injury  

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaw0125 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the catheter was placed with ultrasound, but there was no blood drawback after placement.The physician pulled back the catheter completely and noted there was only 4 cm of the catheter left.The rest, 6 cm, was still in the patient.The surgeon performed a sonogram with echo and an x-ray, but the rest of catheter was not seen.

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 returned sample revealed evidence of use.The catheter was received separate from the deployment system.The catheter wings had been removed from the catheter.The guidewire button had been fully advanced and the safety mechanism was activated over the needle.The guidewire was kinked 1.3cm from the distal tip of the wire.What appeared to be blood residue was observed within the safety mechanism and catheter.The catheter extended 3.5cm from the distal tip of the pink strain relief sleeve, which indicates that approximately 6.5cm 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.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.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) of reaw0125 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the catheter was placed with ultrasound, but there was no blood drawback after placement.The physician pulled back the catheter completely and noted there was only 4 cm of the catheter left.The rest, 6cm, was still in the patient.The surgeon performed a sonogram with echo and an x-ray, but the rest of catheter was not seen.

• Brand Name: POWERGLIDE MIDLINE CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• 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: 6784802
• MDR Text Key: 82387299
• Report Number: 3006260740-2017-01266
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741095443
• UDI-Public: (01)00801741095443
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6020100
• Device Lot Number: REAW0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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: 79 YR