MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T; 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 Problem Great Vessel Perforation (2152)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

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 reeq1360 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that (b)(6) patient hospitalized due to covid-19 has received the picc.Then, it was diagnosed a mediastinum perforation, leading to the picc removal.Additional information received on 8/17/2020: how long after picc insertion was the mediastinum perforation detected? catheter was inserted on (b)(6) at 7pm, and it was removed on the same day, at 11pm.What symptoms did the patient exhibit related to the mediastinal perforation? the catheter, after its insertion, was not released for use by the nurse, due to its unconfirmed point in the intracavitary electrocardiogram.The patient did not present any symptoms.What intervention was provided? the on duty physician of the intensive care unit required support of the vascular team by distance; however, himself removed the picc, the same measure for insertion in the patient was for the its removal.The patient had a chest tomography scheduled, and in this exam that it was possible to see the catheter location.It was inserted a central venous catheter in the femoral vein.Has the patient recovered? the patient was admitted with a diagnosis of septic shock with pulmonary focus and suspected of covid 19, used antibiotics, vasoactive drugs and irritating drugs.Were there any difficulties during the picc insertion? the nurse did not report any difficulty in inserting the catheter, neither in the puncture nor in the progression, but he was unable to confirm the tip on the intracavitary ecg.Was ultrasound and/or 3cg technology used for the picc insertion? it was used ultrasound for puncture and navigation.The image exams are not available for evaluation; however, the customer provides the report based on the chest tomography: central venous catheter with peripheral insertion on the left with an insinuated end in the anterior mediastinum, apparently in an extravascular location, with transfixation of the brachycephalic venous trunk.Small foci of pneumomediastinum and thin liquid sheets between the end of the catheter.Thin pericardial liquid lamina.Tracheal cannula with significant cranial deviation.Large amount of pharyngeal secretion.Small amount of tracheal secretion.Diffuse atheromatosis.Saccular dilation in the wall below the aortic arch, which may correspond to diverticulum in the ductus arteriosus.Other mediastinal structures preserved.Numerous small mediastinal lymph nodes with preserved dimensions.Calcified lymph nodes in the mediastinum and pulmonary hiluses, with a sequelae aspect.Pulmonary consolidations and ground-glass opacities sparse in the right lung, with posterior predominance and more confluent in the right lower lobe, findings suggestive of an inflammatory / infectious process, which can be considered an aspiration etiology.Other faint ground-glass opacities scattered across both lungs, nonspecific.Small pulmonary nodules measuring up to 0.5 cm sparse, some calcified (residual) and others without evident calcification, nonspecific.Reticular opacities associated with some traction bronchiolectasis from the periphery of the lower pulmonary fields, with a chronic interstitial aspect.Laminar pleural effusion on the right.Degenerative changes in the bone framework.Sequelae of fractures in costal arches, more numerous on the left.The images obtained at the thoracoabdominal transition show a distended gallbladder.Hypoattenuating foci sparse by the liver parenchyma, nonspecific by this protocol.Diagnostic printing: central venous catheter for peripheral insertion on the left with insinuated tip into the anterior mediastinum with transfixation of the brachiocephalic venous trunk.

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, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of mediastinum perforation was inconclusive.The reported event could not be verified from the radiographic image that was provided for investigation.The image showed the thoracic region of the patient.The image and complaint information were provided to a radiologist for review, but the reported event could not be confirmed.The placing clinician indicated no abnormalities during product placement and it was unknown if/how the bd catheter related to the patient's condition.The implicated product had been discarded and could not be evaluated.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.Consequently, this complaint is inconclusive at this time and the reported event could not be confirmed as a deficiency in product manufacture or deficiency while under correct product use.

Event Description

It was reported that 94 years old patient hospitalized due to covid-19 has received the picc.Then, it was diagnosed a mediastinum perforation, leading to the picc removal.Additional information received on 8/17/2020: how long after picc insertion was the mediastinum perforation detected? catheter was inserted on 8/05 at 7pm, and it was removed on the same day, at 11pm.What symptoms did the patient exhibit related to the mediastinal perforation? the catheter, after its insertion, was not released for use by the nurse, due to its unconfirmed point in the intracavitary electrocardiogram.The patient did not present any symptoms.What intervention was provided? the on duty physician of the intensive care unit required support of the vascular team by distance; however, himself removed the picc, the same measure for insertion in the patient was for the its removal.The patient had a chest tomography scheduled, and in this exam that it was possible to see the catheter location.It was inserted a central venous catheter in the femoral vein.Has the patient recovered? the patient was admitted with a diagnosis of septic shock with pulmonary focus and suspected of covid 19, used antibiotics, vasoactive drugs and irritating drugs.Were there any difficulties during the picc insertion? the nurse did not report any difficulty in inserting the catheter, neither in the puncture nor in the progression, but he was unable to confirm the tip on the intracavitary ecg.Was ultrasound and/or 3cg technology used for the picc insertion? it was used ultrasound for puncture and navigation.The image exams are not available for evaluation; however, the customer provides the report based on the chest tomography: central venous catheter with peripheral insertion on the left with an insinuated end in the anterior mediastinum, apparently in an extravascular location, with transfixation of the brachycephalic venous trunk.Small foci of pneumomediastinum and thin liquid sheets between the end of the catheter.Thin pericardial liquid lamina.Tracheal cannula with significant cranial deviation.Large amount of pharyngeal secretion.Small amount of tracheal secretion.Diffuse atheromatosis.Saccular dilation in the wall below the aortic arch, which may correspond to diverticulum in the ductus arteriosus.Other mediastinal structures preserved.Numerous small mediastinal lymph nodes with preserved dimensions.Calcified lymph nodes in the mediastinum and pulmonary hiluses, with a sequelae aspect.Pulmonary consolidations and ground-glass opacities sparse in the right lung, with posterior predominance and more confluent in the right lower lobe, findings suggestive of an inflammatory / infectious process, which can be considered an aspiration etiology.Other faint ground-glass opacities scattered across both lungs, nonspecific.Small pulmonary nodules measuring up to 0.5 cm sparse, some calcified (residual) and others without evident calcification, nonspecific.Reticular opacities associated with some traction bronchiolectasis from the periphery of the lower pulmonary fields, with a chronic interstitial aspect.Laminar pleural effusion on the right.Degenerative changes in the bone framework.Sequelae of fractures in costal arches, more numerous on the left.The images obtained at the thoracoabdominal transition show a distended gallbladder.Hypoattenuating foci sparse by the liver parenchyma, nonspecific by this protocol.Diagnostic printing: central venous catheter for peripheral insertion on the left with insinuated tip into the anterior mediastinum with transfixation of the brachiocephalic venous trunk.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T
• 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: 10462978
• MDR Text Key: 207107476
• Report Number: 3006260740-2020-03074
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139529
• UDI-Public: (01)00801741139529
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4275118
• Device Lot Number: REEQ1360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR