MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MICROEZ MICROINTRODUCER SAFETY KIT 3.5F; 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	08/12/2024
Type of Reportable Event	Serious Injury
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that accessed brachial vessel without difficulty (attempted to verify needle in vessel with us and did see blood return) - guidewire would only advance about cm (axilla region).Attempted to insert 3 fr gault introducer (smaller introducer) which would not dilate into vessel.Pulled dilator out of introducer and attempted to just insert dilator (gradually increase opening) but had no luck.Then tried the 3.5 mst introducer (comes in kit with guidewire that fractured).Again was unable to get introducer/dilator to go into the vein.Attempted to remove introducer and met resistance, so pulled guidewire and introducer back out at the same time.On removal saw the guidewire unravel and broken piece of wire near tip of the introducer.When attempting to pull guidewire back it would come out about 1 -2 cm then suck back in.Gps (general pediatric surgery) was called and fellow came to bedside and was eventually able to pull out wire.Xray obtained and no internal guidewire noted on xray.No other information was provided.
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 complaint of a fractured guidewire is confirmed; however, the exact cause is unknown.Four photographs of a guidewire and a microintroducer were returned for evaluation.An initial visual observation of the photographs showed a guidewire inserted into a patient.A microintroducer could be seen in two of the returned photographs; however, no damage could be seen on the microintroducer in either photograph.The guidewire was observed to be unraveled, which indicated the core wire of the guidewire was broken.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that accessed brachial vessel without difficulty (attempted to verify needle in vessel with us and did see blood return) - guidewire would only advance about cm (axilla region).Attempted to insert 3 fr gault introducer (smaller introducer) which would not dilate into vessel.Pulled dilator out of introducer and attempted to just insert dilator (gradually increase opening) but had no luck.Then tried the 3.5 mst introducer (comes in kit with guidewire that fractured).Again, was unable to get introducer/dilator to go into the vein.Attempted to remove introducer and met resistance, so pulled guidewire and introducer back out at the same time.On removal saw the guidewire unravel and broken piece of wire near tip of the introducer.When attempting to pull guidewire back it would come out about 1 -2 cm then suck back in.Gps (general pediatric surgery) was called and fellow came to bedside and was eventually able to pull out wire.Xray obtained and no internal guidewire noted on xray.No other information was provided.

• Brand Name: MICROEZ MICROINTRODUCER SAFETY KIT 3.5F
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20164092
• Report Number: 3006260740-2024-05043
• Device Sequence Number: 20673910
• Product Code: DYB
• UDI-Device Identifier: 00801741038433
• UDI-Public: (01)00801741038433(11)230614(17)270531(10)REHR1245
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 0828935
• Device Lot Number: REHR1245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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