MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Extravasation (1842); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that approximately three weeks post port placement procedure, patient allegedly experienced swelling around the port site.It was further reported that catheter was allegedly fractured upon x-ray examination and the fractured segment had allegedly reached the right ventricle.Reportedly, the fractured segment was retrieved by using snare and the port was removed.The current status of the patient was unknown.

Manufacturer Narrative

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.

Event Description

It was reported that approximately three weeks post port placement procedure, patient allegedly experienced swelling around the port site.It was further reported that catheter was allegedly fractured upon x-ray examination and the fractured segment had allegedly reached the right ventricle.Reportedly, the fractured segment was retrieved by using snare and the port was removed.The current status of the patient was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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.

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 not been returned to the manufacturer for evaluation.However, an image and photos were provided for review.The investigation of the reported event is currently underway.H10: b5, d4 (expiry date: 09/2023).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.H3 other text : device not returned.

Event Description

It was reported that approximately three weeks post port placement procedure, patient allegedly experienced swelling around the port site.It was further reported that catheter was allegedly fractured upon x-ray examination and the fractured segment had allegedly reached the right ventricle.It was also reported that extravasation of normal saline was identified and reported pain from the patient.Reportedly, the fractured segment was retrieved by using snare and the port was removed.The current status of the patient was unknown.

Event Description

It was reported that approximately three weeks post port placement procedure, patient allegedly experienced swelling around the port site.It was further reported that catheter was allegedly fractured upon x-ray examination and the fractured segment had allegedly reached the right ventricle.It was also reported that extravasation of normal saline was identified and reported pain from the patient.Reportedly, the fractured segment was retrieved by using snare and the port was removed.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 mri isp implantable port attached to a groshong catheter in two segments were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.In addition to the returned physical sample, four electronic photos and one electronic image were provided for review.Image review shows a focal disruption of catheter integrity just proximal to the arc of the catheter and it represents an early complication of catheter fracture with subsequent embolization of distal catheter segment.A complete diagonal break was noted on the distal end of the attached catheter and the edges of the complete diagonal break were noted to be uneven.Therefore, the investigation is confirmed for the reported fracture, material separation and migration issues.However, the investigation is inconclusive for the reported fluid leak issue as the exact circumstances at the time of the reported event was unknown.The definitive root cause could not be determined based upon 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.H10: (expiry date: 09/2023).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.

• Brand Name: POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL
• 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: 16324238
• MDR Text Key: 309048079
• Report Number: 3006260740-2023-00376
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REFX2035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 50 KG