MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

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

Patient Problems Death (1802); Thrombus (2101)

Event Date 03/16/2020

Event Type  Death  

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

The following has been reported: midline insert on (b)(6) 2020, a thrombosis was found after 2 days.Implantation without special occurrences.Additional information received (05-june-2020, (b)(6)): (clexane 40mg subcutaneously as before), administration of eliquis 2x5mg (high bleeding risk with thrombocytopenia) starting (b)(6).Due to thrombosis of the v.Basilica, axillaris and subclavia left, from (b)(6) on highly prophylactic liquemin (ufh).Ultrasound images: 1,2,3 above.Thrombosis clearly associated with the catheter.No further complications.After deep vein thrombosis (tvt) no new midline / no central venous catheter (zvk), but peripheral vein catheter (pvk).Patient died on (b)(6) 2020 after a rapidly increasing deterioration in general condition (az) - > however, there is no information provided that the patient's death is associated with the thrombosis.

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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of thrombus was inconclusive due to poor sample condition.Two radiographic images of the left arm catheter insertion area were provided for evaluation.The physical device was not returned.The images were forwarded to a consultant radiologist for review.The findings confirmed the presence of acute thrombus present within the patient and is occluding the vein.The catheter tip is not shown in the images first image provided; however, the second image shows the catheter surrounded by a clot.The catheter was noted to be in the peripheral location of the left arm which could be construed as the arm having a clot present before the placement of the catheter.The patient also experienced a similar event on the right arm which documented in complaint: (b)(4).Although the presence of thrombosis is confirmed, it could not be determined if the catheter was the primary cause of the reported event.Additional possible contributing factors include patient condition, medication treatment, and patient sensitivity.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

The following has been reported: midline insert on (b)(6) 2020, a thrombosis was found after 2 days.Implantation without special occurrences.Additional information received ((b)(6) 2020, mmiller): ¿ (clexane 40mg subcutaneously as before), administration of eliquis 2x5mg (high bleeding risk with thrombocytopenia) starting (b)(6).Due to thrombosis of the v.Basilica, axillaris and subclavia left, from (b)(6) on highly prophylactic liquemin (ufh) ¿ ultrasound images: 1,2,3 above ¿ thrombosis clearly associated with the catheter ¿ no further complications ¿ after deep vein thrombosis (tvt) no new midline / no central venous catheter (zvk), but peripheral vein catheter (pvk) ¿ patient died on (b)(6) 2020 after a rapidly increasing deterioration in general condition (az) - > however, there is no information provided that the patient's death is associated with the thrombosis.

• Brand Name: POWERGLIDE MIDLINE CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10167854
• MDR Text Key: 195571225
• Report Number: 3006260740-2020-02092
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention