MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0607530

Device Problems Entrapment of Device (1212); Fracture (1260); Stretched (1601); Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 06/19/2020

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2021).

Event Description

It was reported that during the port placement through right cephalic, the guide released.The procedure was completed using another device.The patient was expired.

Event Description

It was reported that during the port placement through right cephalic, the metallic guide stretched allegedly in the pink puncture needle with an impossible mobilization.The procedure was completed using another device.The patient was expired.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one introducer needle and one guide-wire were returned for evaluation.Visual, microscopic, functional, and dimensional evaluation(s) were performed.The investigation is confirmed for guidewire fracture, stretching, and immobilization.The guide-wire was inserted into the introducer needle and extended out of the distal end.No anomalies were noted to needle bevel.The guidewire was clearly unraveled from the needle bevel to the j-tip of the guidewire.After functional testing, dried blood and residue were noted on the portion of the guidewire previously inserted within the introducer needle.The broken end of the core wire appeared slightly tapered with burred edges.A 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nursing guide, and unit label) did not find any product labeling inadequacy.¿¿ if the guidewire must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit to prevent the needled from damaging or shearing the guidewire.¿ ¿caution: if the guidewire must be withdrawn while the needle is inserted, remove both needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ h10: b5,d4(expiry date: 12/2021),g4.H11: h6(device, method, result and conclusion).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: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10269152
• MDR Text Key: 198671457
• Report Number: 3006260740-2020-02410
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• Combination Product (y/n): N
• PMA/PMN Number: K022983
• 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: 11/03/2020

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: 0607530
• Device Catalogue Number: 0607530
• Device Lot Number: REDX4220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR