MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 20G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120080
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of reev2236 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported 3cm distal end of guidewire retained in patient upon aborted insertion attempt.Resistance to removal was noted by inserter prior to break.Also noted was a perforation in the catheter, catheter was completely removed however, though wire broke off.Wire was retrieved by interventional radiology.
Event or Problem Description
It was reported 3cm distal end of guidewire retained in patient upon aborted insertion attempt.Resistance to removal was noted by inserter prior to break.Also noted was a perforation in the catheter, catheter was completely removed however, though wire broke off.Wire was retrieved by interventional radiology.Medwatch received stated: "the guidewire of the bd 20g 8cm basic kit powerglide pro midline catheter broke off inside of patient's arm while trying to retract the mechanism.The patient required intervention to retrieve/remove the retained piece of the wire.What was the original intended procedure?: placement of powerglide pro midline catheter.What problem did the user have: device failed.".
Additional 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire and catheter was confirmed.One 20g x 8cm powerglide pro midline catheter was returned for investigation.The sample exhibited evidence of use.What appeared to be dry blood residue was observed on the sample.The catheter was received attached to the wings.The housing was returned for investigation and it was received disassembled.The needle had been removed from the housing and the safety mechanism was engaged over the needle tip.The safety mechanism was removed from the needle.Deformation was observed at the needle bevel.It appears that the material along the edge of the needle bevel was pushed outward, which is consistent with the guidewire being forced against the needle bevel.A 3.5 cm segment of the guidewire was received separate from the remainder of the guidewire, which was attached to the white plate of the housing.A microscopic examination revealed that the adjoining ends of the guidewire were frayed.There was a break in both the core wire and the coil wire.The proximal segment of the coil wire was stretched over the core wire.The adjoining ends of the core wire appeared to be narrowed and angled to one side.A 2mm slit was observed in the powerglide tubing, which was located 1.4cm from the distal tip of the catheter.It appeared that the slit originated within the tubing as a score line was observed within the catheter at the proximal end of the slit.The characteristics observed on the returned catheter are consistent with a needle puncture.It appears that the needle bevel was a contributing factor in the guidewire break.Due to the evidence of use observed on the returned sample, it appears that the user encountered complications during the insertion process.Warnings in the instructions for use (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.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported 3cm distal end of guidewire retained in patient upon aborted insertion attempt.Resistance to removal was noted by inserter prior to break.Also noted was a perforation in the catheter, catheter was completely removed however, though wire broke off.Wire was retrieved by interventional radiology.Medwatch received stated: "the guidewire of the bd 20g 8cm basic kit powerglide pro midline catheter broke off inside of patient's arm while trying to retract the mechanism.The patient required intervention to retrieve/remove the retained piece of the wire.What was the original intended procedure?: placement of powerglide pro midline catheter.What problem did the user have: device failed.".

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11068438
• Report Number: 3006260740-2020-21089
• Device Sequence Number: 2731837
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REEV2236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 05/11/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/28/2021; 06/10/2021
• 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
• Patient Age: 77 YR