MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT MRI ISP 9.6 FR. SILILCONE SINGLE LUMEN CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1859660

Device Problems Break (1069); Fracture (1260); Material Separation (1562); Separation Failure (2547)

Patient Problem Air Embolism (1697)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2021).

Event Description

It was reported that during port placement, the device allegedly broke while being removed from the peel apart sheath.It was further reported that an air embolism occurred in the patient and the radiologist still managed to get the catheter into the patient.The patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one introducer peel-apart sheath was returned for evaluation.Two electronic photos were provided for review.Visual evaluation was performed.The investigation is confirmed for material separation and separation failure from the sample evaluation and photo review as the left side of the peel-apart sheath containing the 10fr imprinted on the handle was returned in two pieces and the trocar valve cover was detached from the left side of the peel-apart sheath.The right side of the peel-apart sheath containing the bard imprinted on the handle contained the trocar valve and two partial breaks were noted to the trocar valve.Based upon the available information, the definitive root cause could not be determined.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: 10/2021), g4.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 during port placement, the device allegedly broke while being removed from the peel apart sheath.It was further reported that an air embolism occurred in the patient and the radiologist still managed to get the catheter into the patient.The patient's current status was unknown.

• Brand Name: POWERPORT MRI ISP 9.6 FR. SILILCONE SINGLE LUMEN CATHETER
• 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
• MDR Report Key: 10926106
• MDR Text Key: 218915260
• Report Number: 3006260740-2020-20730
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222
• Combination Product (y/n): N
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: 1859660
• Device Catalogue Number: 1859660
• Device Lot Number: REEN3565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention