MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO FULL KIT 20G X 10 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F220108PT

Device Problems Material Frayed (1262); Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reet0254 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during insertion resistance was met and there was trouble removing the device.The wire ended up coming off the device completely and it seems it was all removed from patient.No other information was provided.

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 a broken powerglide pro guidewire was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The catheter was advanced and the safety mechanism was engaged.Usage residues were observed throughout the sample.The guidewire exhibited a complete break within the coil/core region.The coil wire was elongated in the vicinity of the break.Microscopic inspection of the break in the core wire revealed a partially granular and partially glossy break surface.Curved shape memory was observed in the vicinity of the break.Microscopic inspection of the needle revealed mechanical damage along the proximal edge of the bevel.The guidewire fracture features and needle bevel deformation were consistent with damage initiated by traumatic contact between the guidewire and the needle.Such damage can occur if the wire is retracted against the needle at a sharp angle.

Event Description

It was reported that during insertion resistance was met and there was trouble removing the device.The wire ended up coming off the device completely and it seems it was all removed from patient.No other information was provided.

• Brand Name: POWERGLIDE PRO FULL KIT 20G X 10 CM
• Type of Device: 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: 11024071
• MDR Text Key: 222770615
• Report Number: 3006260740-2020-20972
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F220108PT
• Device Catalogue Number: F220108PT
• Device Lot Number: REET0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other