MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSTAR; DIALYSIS CATHETER

Model Number 5833690

Device Problems Entrapment of Device (1212); Fracture (1260); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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.H3 other text : device not returned.

Event Description

It was reported that during a dialysis catheter placement procedure in the right atrium via the jugular vein, after the puncture, the guide wire allegedly met resistance while implanting and was difficult to adjust.It was further reported that when the guidewire was found difficult to adjust through the puncture needle, the whole device was removed to adjust, and it was found that the thin wire in the guide wire was allegedly fractured.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm hemostar d/l catheter, one 15.0fr peel-apart sheath and vessel dilator, one 8fr & 12fr dilator, one introducer needle, one j-tip guidewire, one guidewire hoop, one tunneler with a loaded protective sheath and one end cap were returned for evaluation.Gross visual, tactile, dimensional and functional evaluations were performed.The j-tip guidewire was noted to be uncoiled in the distal portion.Both core wires were protruding the coils of the guidewire and noted to have complete breaks on the ends.In addition to the returned physical sample, one electronic photo was provided for review.The photo shows a guidewire was stretched at the distal end and both the round and flat core wires were noted to be broken and protruding.Therefore, the investigation is confirmed for the reported fracture and identified material separation, stretched and unraveled issues.However, the investigation is inconclusive for the reported difficult to advance and physical resistance issues as the exact circumstances at the time of the reported event was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2024).H11: section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during a dialysis catheter placement procedure in the right atrium via the jugular vein, after the puncture, the guide wire allegedly met resistance while implanting and was difficult to adjust.It was further reported that when the guidewire was found difficult to adjust through the puncture needle, the whole device was removed to adjust, and it was found that the thin wire in the guide wire was allegedly fractured.There was no reported patient injury.

• Brand Name: HEMOSTAR
• Type of Device: DIALYSIS 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17115176
• MDR Text Key: 317041176
• Report Number: 3006260740-2023-02400
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REGT2532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG