MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 10CM BASIC; INTRAVASCULAR CATHETER

Model Number	F120100
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional 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 rebt0970 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that while the nurse was placing the device the wire was deployed successfully and as the nurse was pulling the catheter back he met resistance.It was noted that the catheter broke subcutaneously at the 2cm mark.Ultrasound was done and the catheter was not visible.The physician made the decision to leave the catheter at this point.
Additional 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.Two 20g x 10cm powerglide flex catheters were returned for investigation.The returned samples resembled the items in the photograph that was provided for investigation.The catheters were still attached to the wings.No other part of the deployment system was returned for investigation.One catheter was curved near the distal end of the pink sleeve and extended 10cm from the pink strain relieve oversleeve.The other catheter extended 7.6cm from the pink strain relieve oversleeve, which indicates that the distal 2.4cm segment of catheter was missing.The hub of the damaged catheter had been rotated within the wings.A microscopic examination of the damaged catheter revealed a longitudinal slit in the distal end of the catheter segment.The portion of the cross section around the longitudinal split appeared smooth and glossy.Material had been removed from the inside surface of the catheter at the longitudinal slit.These characteristics are consistent with a needle puncture.The complete separation of the catheter most likely occurred after the catheter was punctured with the needle.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.¿ a lot history review (lhr) of rebt0970 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that while the nurse was placing the device the wire was deployed successfully and as the nurse was pulling the catheter back he met resistance.It was noted that the catheter broke subcutaneously at the 2cm mark.Ultrasound was done and the catheter was not visible.The physician made the decision to leave the catheter at this point.

• Brand Name: PG PRO 20G 10CM BASIC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7087801
• Report Number: 3006260740-2017-02186
• Device Sequence Number: 16452639
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F120100
• Device Catalogue Number: F120100
• Device Lot Number: REBT0970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1