MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Pleural Effusion (2010); Great Vessel Perforation (2152)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "picc extravasation".Additional information received 03/18/2020: "on (b)(6) 2020, the patient underwent a cta of the chest.Approximately 50 mls of the contrast, which was being delivered via the picc line, extravasated within the mediastinum and into the right pleural space suggesting a defect or perforation of the superior vena cava.At the present time the main concern in this patient is the fact that she has extravasation of dye into the mediastinum which is concerning for an svc perforation secondary to the picc line.Dr.Has requested a ct of the chest to be obtained stat to rule out any development of any hematoma.As long as patient is hemodynamically stable and no evidence of any hematoma or any worsening leakage dr.Will be planning on possibly removing the picc line tomorrow morning under controlled circumstances in the cath lab.In the meantime, the picc line is to remain in place and not be used.We will try to place peripheral iv access today.Patient will be transferred to the intensive care unit.The duoneb will be discontinued and will start her on atrovent.I will discontinue the amiodarone and put her on amiodarone drip with a bolus again.An echocardiogram has already been requested and is pending.I will start on a lasix drip and monitor electrolytes appropriately.I would keep her n.P.O.Except for medications and sips of water and keep of the head of the bed elevated i will discontinue all types of anticoagulation and put her on dvt prophylaxis via mechanical prophylaxis.(b)(6)-year-old woman who was initially admitted 10 days ago for a total abdominal hysterectomy.She did well and was discharged home last thursday only to be readmitted on friday with bowel obstruction secondary to an incarcerated hernia which did not decompress on its own.She underwent surgical correction and decompression last saturday.Her hospital course was complicated by paroxysmal atrial fibrillation with rapid ventricular rate which initially was placed on amiodarone drip and then switched to amiodarone p.O.And has been relatively stable.She has been on continuous iv fluid hydration and according to patient she has gained close to 30 pounds since her admission.He has developed massive leg edema had progressive dyspnea on exertion.Fluids were stopped today and the patient was started on lasix.With some clinical response.Due to her dyspnea ct of the chest was obtained which revealed bilateral pleural effusions a large one on the right and is small to medium 1 on the left.There was also evidence of extravasation of dye from the svc into the superior anterior mediastinum.Patient kept on going in and out of a.Fib and was good for consultation.Patient denies any prior history of any heart disease except for occasional pvcs for which she sees dr.Patient reports no signs of any prior lung disease.".

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of pleural effusion or perforation of the svc could not be confirmed from the two photographs that were provided for investigation.One photo showed the entire dual-lumen powerpicc solo catheter on a blue drape.The catheter exhibited evidence of use.Residue was observed on the extension legs.The second photo showed a close-up of the solo connectors, extension legs, and proximal end of the molded wing.What appeared to be consistent with tape residue was observed on the extension legs and wing.Since no damage or defects were observed on the sample and no other evidence was provided for investigation, the complaint was conclusive.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "picc extravasation".Additional information received(b)(6)2020 : "on(b)(6)2020 , the patient underwent a cta of the chest.Approximately 50 mls of the contrast, which was being delivered via the picc line, extravasated within the mediastinum and into the right pleural space suggesting a defect or perforation of the superior vena cava.At the present time the main concern in this patient is the fact that she has extravasation of dye into the mediastinum which is concerning for an svc perforation secondary to the picc line.Dr.Has requested a ct of the chest to be obtained stat to rule out any development of any hematoma.As long as patient is hemodynamically stable and no evidence of any hematoma or any worsening leakage dr.Will be planning on possibly removing the picc line tomorrow morning under controlled circumstances in the cath lab.In the meantime, the picc line is to remain in place and not be used.We will try to place peripheral iv access today.Patient will be transferred to the intensive care unit.The duoneb will be discontinued and will start her on atrovent.I will discontinue the amiodarone and put her on amiodarone drip with a bolus again.An echocardiogram has already been requested and is pending.I will start on a lasix drip and monitor electrolytes appropriately.I would keep her n.P.O.Except for medications and sips of water and keep of the head of the bed elevated i will discontinue all types of anticoagulation and put her on dvt prophylaxis via mechanical prophylaxis.74-year-old woman who was initially admitted 10 days ago for a total abdominal hysterectomy.She did well and was discharged home last thursday only to be readmitted on friday with bowel obstruction secondary to an incarcerated hernia which did not decompress on its own.She underwent surgical correction and decompression last saturday.Her hospital course was complicated by paroxysmal atrial fibrillation with rapid ventricular rate which initially was placed on amiodarone drip and then switched to amiodarone p.O.And has been relatively stable.She has been on continuous iv fluid hydration and according to patient she has gained close to 30 pounds since her admission.He has developed massive leg edema had progressive dyspnea on exertion.Fluids were stopped today and the patient was started on lasix.With some clinical response.Due to her dyspnea ct of the chest was obtained which revealed bilateral pleural effusions a large one on the right and is small to medium 1 on the left.There was also evidence of extravasation of dye from the svc into the superior anterior mediastinum.Patient kept on going in and out of a.Fib and was good for consultation.Patient denies any prior history of any heart disease except for occasional pvcs for which she sees dr.Patient reports no signs of any prior lung disease.".

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9879206
• MDR Text Key: 187597403
• Report Number: 3006260740-2020-01021
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9295108D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR