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

Model Number 5393190

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Patient-Device Incompatibility (2682)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 09/2023).

Event Description

It was reported that seven months and nineteen days post catheter placement procedure on the right side, the catheter allegedly broken during removal leaving the inner end inside the patient chest cavity.It was further reported that the physician did a cut down to remove the catheter.There was no reported patient injury.

Event Description

It was reported that seven months and nineteen days post catheter placement procedure on the right side, the catheter allegedly broken during removal leaving the inner end inside the patient chest cavity.It was further reported that the physician did a cut down to remove the catheter.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 19cm glidepath d/l catheter in two segments was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and the identified material separation issues, as a complete circumferential break was noted on the distal end of the catheter.A complete circumferential break was noted on the proximal end of the distal catheter segment.The surface of the complete circumferential break on the distal end of the catheter was noted to be glossy and granular.The surface of the complete circumferential break on the proximal end of the distal catheter segment was noted to be glossy.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 09/2023).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 : see h10.

Event Description

It was reported that seven months and nineteen days post catheter placement procedure on the right side, the catheter allegedly broken during removal leaving the inner end inside the patient chest cavity.It was further reported that catheter was allegedly difficult to remove due to tissue growth over the catheter.Reportedly the physician did a cut down to remove the catheter.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 glidepath d/l catheter in two segments was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.Manufacturing site evaluation of the sample found the catheter was broken.The investigation is confirmed for the reported fracture and material separation issues, as a complete circumferential break was noted on the distal end of the catheter.A complete circumferential break was noted on the proximal end of the distal catheter segment.The surface of the complete circumferential break on the distal end of the catheter was noted to be glossy and granular.However, the investigation is inconclusive for the reported patient-device incompatibility and difficult to remove issue as the exact circumstances at the time of the reported event cannot be verified.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiration date: 09/2023).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.

• Brand Name: GLIDEPATH
• 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: 15578338
• MDR Text Key: 306372697
• Report Number: 3006260740-2022-03947
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012174
• UDI-Public: (01)00801741012174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5393190
• Device Catalogue Number: 5393190
• Device Lot Number: REFY0719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: Black Or African American