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
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006260740-2020-20730
• Device Sequence Number: 10898959
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention