MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN PORT S/L; IMPLANTABLE PORT

Catalog Number 0603880CE

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Arrhythmia (1721); Embolism (1829); Injury (2348)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Medical images were provided for review.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: 07/2023).

Event Description

It was reported that some time post port device implant, the patient experienced pain and arrhythmia.It was further reported x-ray imaging demonstrated that the catheter detached from the port body and migrated into the pulmonary artery.Reportedly, the port catheter was removed from the pulmonary artery via snare, the port body was removed in a separate procedure, and the port device was replaced.The patient status is stable post port replacement.

Event Description

It was reported that some time post port device implant, the patient experienced pain and arrhythmia.It was further reported x-ray imaging demonstrated that the catheter detached from the port body and migrated into the pulmonary artery.Reportedly, the port catheter was removed from the pulmonary artery via snare, the port body was removed in a separate procedure, and the port device was replaced.The patient status is stable post port replacement.

Manufacturer Narrative

H10: manufacturing review: as this is the first reported event for this lot number, a device history review is not required.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one mri low-profile port and one cath-lock were returned for evaluation.Visual, microscopic, functional, and dimensional evaluations were performed.The investigation is confirmed for detachment of the catheter lock and catheter, and migration of the catheter, as the catheter lock was returned separate from the port, and no catheter was on the port stem, and it was found that the x-rays returned depicted an embolized catheter.No breaks or kinks were reported in the image review.The catheter lock inner diameter measurement did not indicate it was out of specification.Five measurements taken of the port stem outer diameter found one of them was out of specification and the others were in specification.The average of the five measurements was 0.0894¿, which is in specification.There was a range between the highest and lowest measurements, indicating a degree of out-of-roundness.Tooling damage was noted to both sides of the port stem.No anomalies were noted to the cath lock.A definitive root cause could not be determined based on the available information.H10: d4 (expiration date: 07/2023).H11: h3, h6 (patient codes, device codes, method, results, conclusion).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: HICKMAN PORT S/L
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9505005
• MDR Text Key: 174525577
• Report Number: 3006260740-2019-03961
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111167
• UDI-Public: (01)00801741111167
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603880CE
• Device Lot Number: REDT3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR