MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606150J

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Suction Problem (2170)

Patient Problem Injury (2348)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (07/2022).The catalog number identified in section has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510k number for the titanium low-profile implantable port, groshong single-lumen, 8f is identified.

Event Description

It was reported that post port device implant procedure via left subclavian vein, during the follow up examination catheter break and the distal catheter segment migrated to the pulmonary artery under computer tomography examination.The distal catheter segment was removed.It was further reported that the port body and the catheter were removed afterwards.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one titanium low-profile port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for catheter break, aspiration issue and catheter migration as the proximal edge of the complete circumferential break was jagged.The surface texture of the break was smooth and rounded as well as granular.Upon infusion of the port body with attached catheter segment, resistance was felt at the port septum.Aspiration was attempted but was unsuccessful.The identified break is typical of flexural fatigue, which is due to the repetitive, kinking of the catheter.The definitive root cause could not be determined based upon available information.However, the ifu states to avoid sharp angles and kinking of the catheter during placement.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: 07/2022),g4,h6(device: 1562).H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510k number for the titanium low-profile implantable port, groshong single-lumen, 8f is identified in d2 and g5.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.

Event Description

It was reported that post port device implant procedure via left subclavian vein, during the follow up examination the catheter allegedly had a break and the distal catheter segment migrated to the pulmonary artery under computer tomography examination.The distal catheter segment was removed.It was further reported that the port body and the catheter were removed afterwards.The patient status is unknown.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10377518
• MDR Text Key: 201994802
• Report Number: 3006260740-2020-02834
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606150J
• Device Lot Number: REBV1519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention