MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 8F SINGLE-LUMEN CV CATHETER; CHRONIC CATHETER

Model Number 7711804

Device Problems Fracture (1260); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Chest Pain (1776); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that approximately seven years and four months post chronic catheter placement in the right side of chest, the catheter allegedly broke off and migrated through heart and to lung.It was further reported that heart catheterization was performed to remove the broken catheter part from the patient's lung.The patient experienced severe chest pain.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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, a photo was provided for review.The investigation of the reported event is currently underway.H10: b5, b7, d4(expiry date: 03/2019).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.H3 other text : device pending return.

Event Description

It was reported that approximately seven years four months post port placement via upper right chest, the catheter was allegedly broke off within patient.It was further reported that the broken parts are migrated through heart and to right lung.Reportedly, the patient experienced severe chest pain.It was further reported that the broken catheter piece was removed from body the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one catheter segment was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned physical sample, one electronic photo, one fluoroscopic video and one medical record was provided for review.The investigation is confirmed for the reported fracture, material separation, migration and identified improper or incorrect procedural method.According to the medical record review, approximately one month post catheter deployment, the patient scheduled for the catheter removal.A 1 to 1.5cm incision was created and the catheter and the cuff were removed in their entirety.Approximately six years and nine months post cvc catheter removal, the patient presented with chest pain and cough with fever.Subsequently, a chest portable 1 view was performed and it revealed a presumed foreign body was again seen within the right main pulmonary artery region likely representing a retained catheter.A computed tomography (ct) chest without contrast was performed and it revealed a linear hyper-density within the right main pulmonary artery and extending into the sub segmental branches of the right lower lobe was favored to represent a retained catheter.Eventually two days later, another chest 2 view was performed, and it revealed a linear radiopaque focus was again seen overlying the right lung consistent with a retained catheter.Also, the electronic photo shows a distal segment of the catheter body and the length of the catheter segment was compared with the plastic fork in the provided photo.In addition to the photo review, the fluoroscopic video shows a snare catheter is placed within the chest and the catheter is traveling up from the abdomen.Near the loops of the snare is an object that appears to be ¿free floating¿ within the lung which resembles a fractured piece of a catheter.Furthermore, during sample evaluation, a complete circumferential break was noted on the proximal end of the catheter segment that was elliptical in shape.Under microscopic observation, the edges of the complete circumferential break on the proximal end of the catheter was noted to be uneven and the surface was noted to be finely granular.A definitive root cause could not be determined, pinch off (damage due to compression of the catheter between the clavicle and first rib) and improper clinician handling could have potentially caused or contributed to the reported event.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.The instruction for use states that, "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." ¿signs of pinch-off clinical: ¿ difficulty with blood withdrawal ¿ resistance to infusion of fluids ¿ patient position changes required for infusion of fluids or blood withdrawal radiologic: ¿ grade 1 or 2 distortion on chest x-ray.Pinch-off should be evaluated for degree of severity prior to explantation.Patients indicating any degree of catheter distortion at the clavicle/first rib area should be followed diligently.There are grades of pinch-off that should be recognized with appropriate chest x-ray as follows¿ preventing pinch-off catheters placed percutaneously or through a cut-down, 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 severance of 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.Catheter removal: warning: warning: you should not feel any resistance when withdrawing the catheter from the vein.If you do encounter resistance, this may indicate that the catheter is being pinched between the clavicle and first rib (the ¿pinch-off¿ sign).Do not continue pulling against resistance as this may cause catheter breakage and embolism.H10: d4(expiry date: 03/2019), g3, h2, h6(device).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 that approximately six years ten months post port placement via upper right chest, the catheter was allegedly broke off within patient.It was further reported that the broken parts are migrated through heart and to right lung.Reportedly, the patient experienced severe chest pain.It was further reported that the broken catheter piece was removed from body.The current status of the patient is unknown.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER
• Type of Device: CHRONIC CATHETER
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14286816
• MDR Text Key: 290766772
• Report Number: 3006260740-2022-01614
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: REYC0493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 90 KG