MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; IMPLANTABLE PORT

Catalog Number 0603880C

Device Problems Break (1069); Suction Problem (2170)

Patient Problems Injury (2348); Palpitations (2467)

Event Date 11/28/2019

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 device was not returned to the manufacturer for evaluation.Photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 09/2020).

Event Description

It was reported that approximately one year post port device implant via right internal jugular vein, the healthcare provider was allegedly unable to aspirate through the port device.It was further reported that the patient allegedly experienced chest distress and palpitation.Therefore, an x-ray imaging was performed which allegedly identified that the catheter fractured and migrated to the heart.Reportedly, the catheter and the port body were removed under digital subtraction angiography (dsa) and upon removal an alleged catheter fracture was identified at the cathlock.The patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.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.Ifu reviewed: baw0735041, rev.0 investigation summary: although the sample was not returned for evaluation, two electronic photo samples were provided for review.The investigation is confirmed for a catheter break at the cathlock, as the photos appear to show the catheter break at the cathlock and the catheter that embolized to the heart.Although a definitive root cause could not be determined, flex fatigue, kinking, and excessive tensile forces could have potentially caused or contributed to the reported event.H10: d4 (expiration date: 09/2020), g4 h11: a3, h6 (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.

Event Description

It was reported that approximately one year post port device implant via right internal jugular vein, the healthcare provider was allegedly unable to aspirate through the port device.It was further reported that the patient allegedly experienced chest distress and palpitation.Therefore, an x-ray imaging was performed which allegedly identified that the catheter fractured and migrated to the heart.Reportedly, the catheter and the port body were removed under digital subtraction angiography (dsa) and upon removal an alleged catheter fracture was identified at the cathlock.The patient status is unknown.

• Brand Name: MRI L/P PORT W/BROV 6.6F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9583846
• MDR Text Key: 175103152
• Report Number: 3006260740-2019-04125
• 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: 06/18/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: REBX0617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 60