MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F118080
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the powerglide pro was placed in the patient's left upper arm.It was stated that initially the device was functional and had blood return; but later the same day it became non-functional and the rn's were unable to remove it.X-ray showed the catheter was kinked inside the patient's arm.Vascular surgery removed most of the catheter, however 2cm of it remained in arm.
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 catheter was confirmed and was determined to be related to use of the device.Two 18g powerglide catheters that were labeled as 8cm were returned for investigation.The catheters were received separate from the deployment system.One catheter was 8cm in length.The other catheter was 5.7cm in length, which indicates that approximately 2.3cm of the catheter was missing.A tacky residue was observed on a 2.7cm segment of the shorter catheter just distal to the green oversleeve.The distal end of the damaged catheter was not returned for investigation.A microscopic examination revealed that the catheter was scored longitudinally within the lumen at the distal tip of the returned segment.The characteristics observed on the returned damaged catheter are consistent with a needle puncture, which most likely occurred at the time of placement.Warnings in the ifu indicate that 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 indicates to not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.Due to the evidence of use and the characteristics of the damage, the complaint was determined to be use related.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 or Problem Description
It was reported that the powerglide pro was placed in the patient's left upper arm.It was stated that initially the device was functional and had blood return; but later the same day it became non-functional and the rn's were unable to remove it.X-ray showed the catheter was kinked inside the patient's arm.Vascular surgery removed most of the catheter, however 2cm of it remained in arm.

• Brand Name: PG PRO 18G 8CM BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7364209
• Report Number: 3006260740-2018-00503
• Device Sequence Number: 16573613
• Product Code: FOZ
• UDI-Device Identifier: 00801741110504
• UDI-Public: (01)00801741110504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: F118080
• Device Catalogue Number: F118080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention