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

Model Number	5303230
Medical Device Problem Codes	Difficult to Flush (1251); Deformation Due to Compressive Stress (2889); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 06/2022).
Event or Problem Description
It was reported that during a procedure, the peel away sheath on the device was unable to be peeled away and required scissors to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the peel away sheath on the device was unable to be peeled away and required scissors to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation, one medical image was provided for review.The investigation is confirmed for the reported catheter kink issue as the catheter is kinked before descending towards the right heart in the provided image.However, the investigation is inconclusive for the reported difficult or delayed separation and difficult to flush as the device was not returned for evaluation and the exact circumstances at the time of the reported event are unknown.A definitive root cause could not be determined.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 (expiry date: 06/2022), g3.H11: h6 (result).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.

• Brand Name: GLIDEPATH DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; parque industrial colonial; salt lake city 84116
• MDR Report Key: 10667910
• Report Number: 3006260740-2020-20065
• Device Sequence Number: 19583196
• Product Code: MSD
• UDI-Device Identifier: 00801741187322
• UDI-Public: (01)00801741187322
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 5303230
• Device Catalogue Number: 5303230
• Device Lot Number: REEU2822
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other