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); Migration (4003); Material Split, Cut or Torn (4008)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device (has or has not) been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2023).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 year five months and twenty-three days post port placement in the right internal jugular vein, port body alleged leaked subcutaneously.It was further reported that catheter allegedly broken and catheter segments were removed.Reportedly the distal catheter segment had perforated the wall of the superior vena cava and migrated to the right atrium and remains inside of the patient¿s body.Patient allegedly developed mediastinitis.The current status of the patient 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 powerport isp mri implantable port attached to the groshong catheter were received for evaluation.Visual, microscopic, tactile and functional evaluations were performed.A complete circumferential break was noted at the distal end of the attached catheter that was elliptical in shape.What appeared like a split, was noted on the port septa.Tool damage was not noted to the cath-lock.The edges of the complete circumferential break on the distal end of the attached catheter were noted to be uneven and the surface was noted to be round and smooth in one region and granular in the other region.Upon infusion, thrombus with water was observed exiting the port stem.Therefore, the investigation is confirmed for the reported fracture, leak and material separation and identified material split, wear and deformation issues.However the investigation is inconclusive for the reported migration issues as there was no objective evidence obtained.A definitive root cause could not be determined, flexural fatigue (repeated/cyclic kinking of the catheter which can cause gradual tearing in the catheter) 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.H10: d4 (expiry date: 08/2023), 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 year five months and twenty-three days post port placement in the right internal jugular vein, port body alleged leaked subcutaneously.It was further reported that catheter allegedly broken and catheter segments were removed.Reportedly the distal catheter segment had perforated the wall of the superior vena cava and migrated to the right atrium and remains inside of the patient¿s body.Furthermore, patient allegedly developed mediastinitis.The current status of the patient was unknown.

• 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: 17169517
• MDR Text Key: 317533334
• Report Number: 3006260740-2023-02535
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: REFS4602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 53 KG