MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 9274108D

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 05/09/2018

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recp1588 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the picc was placed on (b)(6) 2018 "svc - cavoatrial junction." the picc was "cut at 32 cm, but inserted at 33 cm, plus one - up to the hub." on (b)(6) 2018, the purple lumen became occluded.The nurse successfully used alteplase to dissolve the clot.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an occluded catheter was inconclusive because the reported event could not be verified in the vad field assurance laboratory.The product returned for evaluation was one 4fr d/l powerpicc sv catheter.Usage residues were observed throughout the sample.The catheter terminated at the 32cm depth marking.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion.Blood residue was cleared from both lumens; however, no resistance to infusion was observed.No occlusions were observed; however, the event description indicated that the reported occlusion was successfully cleared using alteplase.A cleared occlusion could not be verified.Consequently this complaint is inconclusive at this time.Blood product occlusion can occur if the catheter is not maintained properly.The product ifu provides guidance for catheter maintenance using heparinized saline.A lot history review (lhr) of recp1588 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the picc was placed on (b)(6) 2018 "svc - cavoatrial junction." the picc was "cut at 32 cm, but inserted at 33 cm, plus one - up to the hub." on (b)(6) 2018, the purple lumen became occluded.The nurse successfully used alteplase to dissolve the clot.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7584502
• MDR Text Key: 111009486
• Report Number: 3006260740-2018-01314
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035678
• UDI-Public: (01)00801741035678
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9274108D
• Device Catalogue Number: 9274108D
• Device Lot Number: RECP1588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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 Age: 58 YR
• Patient Weight: 53