MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT; IMPLANTED PORTS

Model Number	1718500
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device was returned for evaluation.The investigation of the reported event is currently underway.Expiry date (12/2021).
Event or Problem Description
It was reported that approximately one year nine months post port placement, the catheter allegedly ruptured during ct angio injection.It was further reported that the patient had contrast extravasation from the port area and the port was removed from 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.Investigation summary: one powerport slim attached to a groshong catheter was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture, deformation due to compressive stress and naturally worn as a circumferential split was noted approximately 3.5cm from the distal end of the cath-lock and a partial circumferential break was noted approximately 5.8cm from the distal end of the cath-lock.The edges of the circumferential split were jagged, with granular surfaces.The edges of the partial circumferential break were jagged, with both granular and rounded surfaces.The identified fracture is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.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: d4 (expiry date: 12/2021).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 approximately one year and nine months post port placement, the catheter allegedly ruptured during ct angio injection.It was further reported that the patient had contrast extravasation from the port area and the port was removed from the patient.The patient status was unknown.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT
• Common Device Name: IMPLANTED PORTS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10671670
• Report Number: 3006260740-2020-20081
• Device Sequence Number: 14203173
• Product Code: LJT
• UDI-Device Identifier: 00801741026812
• UDI-Public: (01)00801741026812
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 1718500
• Device Catalogue Number: 1718500
• Device Lot Number: RECX2365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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
• Patient Age: 53 YR
• Patient Weight: 80