MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602830

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Cardiac Perforation (2513); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2020).Device not returned.

Event Description

It was reported that approximately one month post placement, the catheter allegedly fractured and embolized to the right atrium.It was further reported that additional intervention was performed to remove the foreign body from heart and replace the malfunctioning port.The current patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, a medical record review was performed.The investigation is confirmed for the reported catheter fracture, migration and material separation issue.According to the medical record, through the left subclavian vein approach, a pocket was made on anterior chest wall and the port was implanted.Approximately one month and twelve days post port deployment, patient developed pinch-off syndrome which resulted in catheter fracture and embolization of tubing fragment into the superior vena cava.Subsequently, the patient presented for endovascular retrieval of foreign body and right chest port placement.An x-ray chest was performed which revealed that the catheter tubing fragment extending from the mid left brachiocephalic vein, extending to the superior vena cava and appearing to terminate in the right atrium in the region of the tricuspid valve.On the same day, through the right common femoral vein approach, an angiographic catheter was used to manipulate the embolized catheter fragment, effectively removing it from the right atrium.The catheter fragment was then snared with amplatz gooseneck snare and removed from the intravascular space.Then through the right internal jugular vein approach, a catheter was inserted with the tip at the cavoatrial junction and new port was assembled and flushed.The port was accessed and flushed.A definitive root cause could not be determined based upon the available information.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.Instruction for use reviewed: the current instruction for use states that: contraindications: ¿ this device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off.Preventing pinch- off the risk of pinch-off syndrome can be avoided by inserting the catheter via the internal jugular vein (ij).Subclavian insertion of the catheter medial to the border of the first rib may cause catheter pinch-off, which in turn results in occlusion causing port system failure during power injection.If you choose to insert the catheter into the subclavian vein, it should be inserted lateral to the border of the first rib or at the junction with the axillary vein because such insertion will avoid compression of the catheter, which can cause damage and even sever the catheter.The use of image guidance upon insertion is strongly recommended.A radiographic confirmation of catheter insertion should be made to ensure that the catheter is not being pinched.H11: section a through f: the information provide by bd represents all 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 through the litigation process that approximately one month post placement, the catheter allegedly fractured and embolized to the right atrium.It was further reported that additional intervention was performed to remove the foreign body from his heart and replace the malfunctioning port.The current patient status was unknown.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11671859
• MDR Text Key: 245588427
• Report Number: 3006260740-2021-01336
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025716
• UDI-Public: (01)00801741025716
• Combination Product (y/n): N
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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 Model Number: 0602830
• Device Catalogue Number: 0602830
• Device Lot Number: REZF1449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN, BACLOFEN, CITALOPRAM; ACETAMINOPHEN, BACLOFEN, CITALOPRAM; IBUPROFEN, INSULIN, LEVOTHYROXINE; IBUPROFEN, INSULIN, LEVOTHYROXINE; LISINOPRIL-HYDROCHLOROTHIAZIDE, ONDANSETRON; LISINOPRIL-HYDROCHLOROTHIAZIDE, ONDANSETRON; OXYBUTYNIN, OXYCODONE; OXYBUTYNIN, OXYCODONE; ACETAMINOPHEN, BACLOFEN, CITALOPRAM; IBUPROFEN, INSULIN, LEVOTHYROXINE; LISINOPRIL-HYDROCHLOROTHIAZIDE, ONDANSETRON; OXYBUTYNIN, OXYCODONE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98