MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 10CM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "complicated midline insertion in a patient with low venous capital with a first guide insertion failure.The second guide used is inserted up to an obstacle, it remains stuck.Removal by the nurse of the guide + needle.A frayed/loose guide was found.In total: fragmentation of the guide with a foreign body left in the intravenous line.Consequences for the patient: endovascular procedure under local anesthesia to remove the fragment: failure.The fragment left in place with intraparietal portion at the level of the basilic vein.Weekly radiographic monitoring is instituted for 1 month with anticoagulation.The incident was isolated and occurred during anesthesia.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv3805 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "complicated midline insertion in a patient with low venous capital with a first guide insertion failure.The second guide used is inserted up to an obstacle, it remains stuck.Removal by the nurse of the guide + needle.A frayed/loose guide was found.In total: fragmentation of the guide with a foreign body left in the intravenous line.Consequences for the patient: endovascular procedure under local anesthesia to remove the fragment: failure.The fragment left in place with intraparietal portion at the level of the basilic vein.Weekly radiographic monitoring is instituted for 1 month with anticoagulation.The incident was isolated and occurred during anesthesia.".
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 frayed guidewire is confirmed but the exact cause remains unknown.One guidewire and one product label were returned for evaluation.The product sticker label indicated lot: refv3805.The distal end of the core wire and coil wire was frayed.The guidewire length measured to be 64.3 cm which indicates that a 5.7 cm section of the guidewire was fractured and not returned.The introducer needle used in conjunction with the guidewire was not returned.The outer diameter of the guidewire was measured at an undamaged region and was found to be within manufacturing specification.Based on the information provided and returned sample, possible contributing factors include retraction of the guidewire against the needle bevel and forceful removal against resistance.Since the guidewire was found to be frayed and missing a portion of the wire, the complaint is confirmed but the exact factors remain unknown.

• Brand Name: RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 10CM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14117958
• Report Number: 3006260740-2022-01309
• Device Sequence Number: 17222006
• Product Code: DYB
• UDI-Device Identifier: 00801741074578
• UDI-Public: (01)00801741074578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: N/A
• Device Catalogue Number: 0669045
• Device Lot Number: REFV3805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: Required Intervention
• Patient Sex: Unknown