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

Model Number 9808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

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

Event Date 07/15/2022

Event Type  malfunction  

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.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately seven years post port placement, the catheter was allegedly broken.There was no reported patient injury.

Manufacturer Narrative

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, microscopic visual, tactile evaluation and functional testing were performed.The investigation is unconfirmed for the reported material separation issue as the catheter was found intact and no segments of catheter was returned for evaluation.However, the investigation is confirmed for the reported catheter fracture and fluid leak and identified deformation and wear issues as a split was noted on the attached catheter approximately 0.1cm from the distal end of the cath-lock.Further, a partial circumferential break and partial compound break were noted on the attached catheter approximately 1.4cm and 2.0cm from the distal end of the cath-lock respectively.Under microscopic observation, the edges of the partial circumferential break on the attached catheter was noted to be uneven.Also, the edges of the partial compound break on the attached catheter was noted to be jagged and the surface was noted to be round in one region and granular in the one region.Upon infusion, a leak from both partial breaks on the attached catheter were noted.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.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.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 seven years post port placement procedure via the right internal jugular vein, the device allegedly had leak.It was further reported that the catheter was allegedly broken.Reportedly the distal catheter segment and the port body were removed.The procedure was completed using another device.There was no reported patient injury.

• 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: 15181811
• MDR Text Key: 302606206
• Report Number: 3006260740-2022-03085
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 56 KG