MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F BASIC TRAY WITH MICROINT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 1194118

Device Problem Mechanics Altered (2984)

Patient Problem Death (1802)

Event Date 10/27/2015

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reze1532 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a picc was inserted on the venous side but on insertion the picc allegedly tied into a knot.Patient was taken to medical imaging where the reported knot in the picc was confirmed and picc was removed femorally.A new picc was inserted with no complications.Patient died the following day.No autopsy was performed as the hospital felt it wasn't related to the picc insertion and it was a coincidence.The clinician felt the cause of death was due to an embolic shower from patient's necrotic toes (type 1 diabetic).

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 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 a knotted catheter was confirmed but the cause remains unknown.The product returned for evaluation was one 4fr single-lumen powerpicc solo catheter.Usage residue was observed throughout the catheter.A knot in the catheter material was observed at the 45cm depth marking.Tactile evaluation of the sample confirmed a knot in the catheter with slight tensile weakness throughout.Microscopic examination of the sample revealed no manufacturing defects or deformities in the catheter material.No evidence was found on the sample that would have contributed to the knotting of the catheter.Although the cause of this event is unknown, the knotted region may be related to insertion technique.This can occur by moving the catheter forward, twisting it, and then retracting it, all through a tortuous path.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F BASIC TRAY WITH MICROINT
• 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: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5221483
• MDR Text Key: 31397980
• Report Number: 3006260740-2015-00532
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527(17)160928(10)REZE1532
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1194118
• Device Lot Number: REZE1532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death