MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0603880

Device Problems Fracture (1260); Material Separation (1562); Dent in Material (2526); Migration (4003)

Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately four years and ten months post port placement in subclavian artery, the catheter was allegedly fractured.It was further reported that the fragment embolized to the pulmonary artery and main branches bilaterally.Reportedly, catheter fragment was removed.The current status of the patient is unknown.

Event Description

It was reported that approximately four years and ten months post port placement in subclavian artery, the catheter was allegedly fractured.It was further reported that the fragment embolized to the pulmonary artery and main branches bilaterally.Reportedly, catheter fragment was removed.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 was performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2021) h6 (method).H11: d1, d4 (medical device catalog, medical device lot).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.H3 other text: device not returned.

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 bardport mri implantable port, one catheter segment and a cath-lock loaded with a catheter segment were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.A complete circumferential break was noted on proximal end of the catheter segment catheter segment.However, striations were noted throughout.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported fracture, material separation and the identified dent issues, as complete circumferential breaks were noted on the distal end of the loaded catheter on the cath-lock and the distal end of the catheter segment.A split was noted on the catheter segment approximately 0.8cm from the proximal end.The surface of the complete circumferential break on the proximal end of the catheter segment returned was noted to be granular and glossy.The surfaces of the distal end of the catheter attached to the cath-lock and complete circumferential break on the distal end of the catheter segments were noted to be granular and glossy.However, the investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.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.H10: d4 (expiry date: 08/2021), g3, h2, h6 (device) 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 four years and ten months post port placement in subclavian artery, the catheter was allegedly fractured.It was further reported that the fragment embolized to the pulmonary artery and main branches bilaterally.Reportedly, catheter fragment was removed.The current status of the patient is unknown.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15162210
• MDR Text Key: 297209583
• Report Number: 3006260740-2022-03033
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025877
• UDI-Public: (01)00801741025877
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K873213
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0603880
• Device Catalogue Number: 0604580
• Device Lot Number: REAV1465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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: 66 YR
• Patient Sex: Male