MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH M

Catalog Number 9194108D

Device Problems Material Fragmentation (1261); Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem Embolism (1829)

Event Date 01/09/2014

Event Type  Injury  

Event Description

Per medwatch: during picc insertion, was inserting picc with sherlock wire into sheath.Sherlock sensor indicated picc was not advancing into svc as expected.Withdrew sherlock wire, wire would not retract.Advanced picc, was then able to retract wire.Inserted stiff wire into picc, advanced catheter easily over stiff wire.Examined tip of sherlock wire to re-insert for tip placement confirmation, noted that magnetic tip was missing from the sherlock wire.Retracted picc, capped dilator and replaced it into sheath.Flushed picc catheter to determine if magnetic tip fragment was inside, tip not found.Informed md, obtained stat shoulder x-ray, revealing tip fragment overlying expected area of axillary vein.

Manufacturer Narrative

The device has not been returned to the mfr, at this time, for eval.A lot history review (lhr) of rexj1297 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH M
• Manufacturer (Section D): C.R. BARD, INC. (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3772765
• MDR Text Key: 4431535
• Report Number: 3006260740-2014-00090
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9194108D
• Device Lot Number: REXJ1297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 43