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

Catalog Number 9808560

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided 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 three years, four months and twenty seven days post a port procedure, the catheter was allegedly damaged.It was further reported that the catheter was removed.There was no reported patient injury.

Event Description

It was reported that approximately three years, four months, and twenty-seven days post a port placement, the patient allegedly experienced pain while administering medication during chemotherapy.It was further reported that the catheter damage was allegedly confirmed during the contrast imaging.Reportedly, the port system was removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic, tactile and functional evaluation were performed.A compound break was noted approximately 4.7cm from the distal end of the cath-lock.The edges of the compound break on the attached catheter were noted to be uneven.The surface was noted to be round and smooth on both regions.Splits were noted on the border of both regions.Upon infusion, a leak of water with thrombus from the compound break was observed.Aspiration was attempted and was unsuccessful.Therefore, the investigation is confirmed for the reported material integrity and identified fracture, wear and deformation issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, g3, h6 (device).H11: e1, h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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.

• Brand Name: POWERPORT ISP 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
• 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: 18920391
• MDR Text Key: 337851968
• Report Number: 3006260740-2024-01144
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/22/2024
• 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