MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when radiology doctor is trying to insert a dual lumen picc today, a guide wire was stuck inside one lumen of a dual lumen picc.To maintain the access, we opened another dual lumen kit, used the 135cm long wire that comes in the dual lumen picc pack to swap out the picc that has wire stuck inside.No harm caused to the patient, we just had to spend longer time for this procedure.(b)(6) 2022 - multiple bends and a sharp kink were observed within the coil region of the returned guidewire.
Additional Manufacturer Narrative
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 difficulty advancing the catheter over the guidewire was confirmed.The product returned for evaluation was one 5fr d/l powerpicc catheter and one 135cm guidewire.Light usage residues were observed throughout the sample.Multiple bends were observed along the length of the guidewire and a sharp kink was observed within the coil region.The guidewire outer diameter was measured to be 0.018¿ using digital calipers.Microscopic inspection of the guidewire confirmed bends in the guidewire, a kink in the coil region and the presence of biological residue.Attempts to insert the guidewire through the catheter were unsuccessful.Resistance was encountered when attempting to pass the bent regions of the wire through the catheter.Insertion of a non-complainant 0.018¿ stainless steel guidewire through the catheter was successful and unremarkable.The difficulty encountered when advancing the catheter over the guidewire was caused by the bends/kink in the wire.The wire deformation was consistent with wire advancement/manipulation against resistance and the biological residue suggested that manipulation occurred during device use.A lot history review (lhr) of refq0140 showed no other similar product complaint(s) from this lot number.

• Brand Name: RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14496970
• Report Number: 3006260740-2022-01947
• Device Sequence Number: 6150894
• Product Code: DYB
• UDI-Device Identifier: 00801741074592
• UDI-Public: (01)00801741074592
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: N/A
• Device Catalogue Number: 0669060
• Device Lot Number: REFQ0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown