MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5FX 32CM TITAN HD CATHETER; TITAN CATHETER

Model Number THD155032.

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Per-dialytic bleeding from the tunneled hemodialysis catheter (inserted in 2018), on "spontaneous" rupture.Consequences noted: need for antibiotic therapy.Incident occured on a friday evening, clamping of the catheter for the weekend, with umbilical cord clamps recovered from the maternity hospital (no clamp adapted to this type of incident in our department).Change of the catheter in semi-emergency (at day 3), which was difficult for this patient (in relation with the anatomical characteristics of the patient) with the need for a return to the vascular surgery block and hospitalization.Significant bleeding at the time of the change with the need for a transfusion.

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Per-dialytic bleeding from the tunneled hemodialysis catheter (inserted in 2018), on "spontaneous" rupture.Consequences noted: need for antibiotic therapy.Incident occured on a friday evening, clamping of the catheter for the weekend, with umbilical cord clamps recovered from the maternity hospital (no clamp adapted to this type of incident in our department).Change of the catheter in semi-emergency (at day 3), which was difficult for this patient (in relation with the anatomical characteristics of the patient) with the need for a return to the vascular surgery block and hospitalization.Significant bleeding at the time of the change with the need for a transfusion.

Manufacturer Narrative

The titan catheter was returned with approximately 5 cm of the lumen attached to the hub.Visual inspection confirms the complaint as the hub is cracked.The crack begins at the most distal end of the hub, travels under the attached suture wing, and continues up the hub approximately 0.3 cm at an angle.The work order for this catheter lot was reviewed by medcomp engineering and the device contract manufacturer conducted a review of the manufacture records for the lot number reported.These investigations revealed the device was manufactured and inspected according to specification.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or weak spots if they had existed at the time of manufacture.The device was implanted for a period of four (4) years with no issues.The circumstances that may have contributed to the complaint condition cannot be determined.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 15.5FX 32CM TITAN HD CATHETER
• Type of Device: TITAN CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13497442
• MDR Text Key: 285715807
• Report Number: 2518902-2022-00017
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908053036
• UDI-Public: 884908053036
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: THD155032.
• Device Catalogue Number: THD155032.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 69 KG