MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number S1385108D

Device Problems Kinked (1339); Occlusion Within Device (1423)

Patient Problems Death (1802); Septic Shock (2068)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reas1552 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales representative, nurse reported that on (b)(6) 2016 they placed a provena picc in the ij of a patient with comorbidities.Nurse stated that the picc kinked and clotted.The patient then coded and medication was stopped.Medical personnel revived the patient.The picc was left in the ij and currently remains in the patient.Nurse called the sales representative on (b)(6) 2016 and reported that they plan to take the patient off of life support today ((b)(6) 2016).On 9/9/2016 - additional information received: nurse reported that the patient was in intensive care before the picc was placed and was "very sick".Nurse expected the patient to arrest during procedure because of the state of the patient's health.A picc was placed in the right ij and had good blood flow to all three lumens.The reported kink noticed at time of placement was described as a slight bend in the catheter and did not look like a hard bend or sharp turn.Nurse reported that after the picc was placed successfully, nurses came back to him within 1-2 hours reported that the picc was not flushing.It was then decided to place a femoral line in the patient to administer medications.The patient coded during the delay of medications and was revived by staff.After revival, the patient was discharged to hospice care with the picc remaining in place.Patient later passed away.Nurse reported that they could not recall the age of the patient but that they were of medium build and estimated their weight to be around (b)(6).Nurse stated that the diameter of the picc was less than 10% than that of the vessel diameter.On (b)(6) 2016 - information clarified by sales representative and contact: facility uses piccs off-label by placing them as cvc lines.The picc in this event was placed as a cvc.On (b)(6) 2016 - facility states the picc kinked at the 2cm depth mark.On (b)(6) 2016 - spoke to the icu nurse caring for this patient.This patient was a 58 year old female with septic shock.They placed a tl picc line to give vasopressin and levophed to keep her blood pressure up.The nurse went into the room to draw labs.She flushed the third lumen and withdrew 10ml of blood successfully.She placed the transfer device on the lumen and inserted the lab tube into the transfer device.Blood began to fill the lab tube but then stopped.The nurse disconnected the transfer device and attempted to flush the line with saline but was unsuccessful.At this time, the pump began to beep indicating there was an occlusion in the first and second lumens, which were infusing vasopressors.The patient went into cardiac arrest.The staff performed cpr with chest compressions for about 5 minutes.At this time, a new catheter was placed in the femoral vein and the vasopressors were restarted along with an epinephrine drip.The patient was revived.She continued to be in a poor state of health.The patient expired on (b)(6) 2016 in the icu (she was never discharged to hospice).The picc was removed at that time and discarded.The nurse did not know what caused the picc to become occluded suddenly in all three lumens.She states she did not notice a kink in the line and states the line was in the same state as when it was placed.She states after the patient was revived, the picc nurse came up and was able to flush the picc and aspirate blood.The icu nurse states the patient's labs indicated she was in dic which causes bleeding and clotting at the same time so she wondered if she aspirated a clot when she attempted the draw labs.She states if this is the case, the clot may have been dislodged during chest compressions, allowing the picc nurse to flush and draw blood after the code.However, she doesn't know for sure why the occlusion occurred in all three lumens or if the dic contributed to the occlusions.

Manufacturer Narrative

The information provided by bard 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 bard.Mdr classification was changed to a serious injury after receiving additional information on (b)(6) 2016.The patient was said to be in septic shock and unable to sustain blood pressure without vasopressors.The patient also was in dic.The patient expired the day following the event of inability to infuse through the picc.As such, this will be reported as a serious injury as it is reasonable to suggest the temporary event of inability to infuse did not cause or contribute to the patient's death.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5949420
• MDR Text Key: 54678412
• Report Number: 3006260740-2016-00481
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720(17)170528(10)REAS1552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Catalogue Number: S1385108D
• Device Lot Number: REAS1552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR