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

Model Number 0606150

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Reflux within Device (1522); Material Separation (1562); Dent in Material (2526); Migration (4003); Air/Gas in Device (4062)

Patient Problems Extravasation (1842); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/24/2021

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.However, photos and images were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2025).

Event Description

It was reported that one month post port placement, through subclavian vein, the catheter allegedly broke, which caused a rupture and surgical intervention.It was further reported that during removal, the distal part of catheter was migrated to the cardiac chamber, which was removed through a femoral catheterization.The procedure was completed using another device.The patient's current status was unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ti low profile implantable port attached to a groshong catheter in two segments were returned for evaluation, three electronic photos and two medical images were provided for review.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture, material separation, fluid leak and identified dent in material issues as a complete circumferential break was noted approximately 5.0cm from the distal end of the cath-lock.The dital end of the first catheter segment and proximal end of the second catheter segment was elliptical in shape.The investigation is also confirmed for the identified reflux within device issue as blood return was noted upon infusing the port body with attached catheter segment.Further the investigation is also confirmed for the reported migration issue as a segment of catheter was found near the left heart in the provided medical image.However, the investigation is inconclusive for the reported air/gas in device issue as the exact circumstances at the time of the reported event are unknown.The definitive root cause could not be determined based upon 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.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 one month post port placement through the subclavian vein, the catheter allegedly fractured and caused the catheter to rupture.It was further reported that during port removal, the distal part of catheter migrated to the cardiac chamber.Reportedly, the device was removed through a femoral catheterization.Another port was implanted.The patient is currently stable.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ti low profile implantable port attached to a groshong catheter in two segments were returned for evaluation, three electronic photos and two medical images were provided for review.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture, material separation, fluid leak and identified dent in material issues as a complete circumferential break was noted approximately 5.0cm from the distal end of the cath-lock.The distal end of the proximal catheter segment was elliptical in shape.During functional evaluation, the catheter segment was unable to infuse and blood return was observed during infusion, however these issues were identified during sample evaluation in laboratory conditions, therefore the investigation is inconclusive for the reported air/gas in device issue.The investigation is also inconclusive for the reported migration issue as the provided medical image is not sufficient enough to confirm the issue as well the exact circumstances at the time of the reported event are unknown.The definitive root cause could not be determined based upon 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.Instructions for use reviewed and states: "pinch-off prevention: catheters placed percutaneously or through a cutdown, into the subclavian vein, should be inserted at the junction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet.The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even sever the catheter.A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.1,2" 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 one month post port placement through the subclavian vein, the catheter allegedly fractured and caused the catheter to rupture.It was further reported that during port removal, the distal part of catheter migrated to the cardiac chamber and extravasation was allegedly noted.Reportedly, the device was removed through a femoral catheterization.Another port was implanted.The patient is currently stable.

• Brand Name: TITANIUM LOW-PROFILE 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12292191
• MDR Text Key: 265558632
• Report Number: 3006260740-2021-03198
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0606150
• Device Catalogue Number: 0606150
• Device Lot Number: REEZ1942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Male