MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Material Frayed (1262); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 11/29/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reew1837 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "attempted picc insertion via right brachial vessel.Met resistance with 20cm of picc inserted.Pulled picc back and rotated patients' arm (through the drape).Advanced picc with resistance again met at the 20cm mark.Pulled picc completely out.At the tip of the picc a long blood clot was noted.I used gauze to gently remove blood clot from the end of the picc.At this time, i noted that the stylet appeared to be protruding 1cm from the distal end of the picc.I thought the stylet had migrated.I pulled the stylet out 3cm at the hub but noticed that 1cm of the stylet was still showing at the distal picc opening.I pulled the entire stylet out of the picc.At this point, i gently removed the stylet wire that was still protruding and realized that a 2.5cm piece of the stylet wire had detached from the stylet.The remaining portion of the stylet was not bent or kinked.The picc was not bent or kinked.".

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 a damaged stylet was confirmed, but the exact mechanism of damage could not be determined from the two photographs that were provided for investigation.One photograph showed the label of the powerpicc.The second photo showed the 3cg stylet with what appeared to be a break in the polyimide tubing.A segment of polyimide tubing was shown in the tray separate from the remainder of the stylet.The loose segment of stylet appeared to be kinked.It was reported that the resistance was met during insertion.The resistance was reportedly present before and after rotating the patient¿s arm.Kinking of the polyimide tubing and advancement against resistance may have been potential contributing factors in the observed damage; however, the exact cause of the reported event could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿.

Event Description

It was reported "attempted picc insertion via right brachial vessel.Met resistance with 20cm of picc inserted.Pulled picc back and rotated patients' arm (through the drape).Advanced picc with resistance again met at the 20cm mark.Pulled picc completely out.At the tip of the picc a long blood clot was noted.I used gauze to gently remove blood clot from the end of the picc.At this time, i noted that the stylet appeared to be protruding 1cm from the distal end of the picc.I thought the stylet had migrated.I pulled the stylet out 3cm at the hub but noticed that 1cm of the stylet was still showing at the distal picc opening.I pulled the entire stylet out of the picc.At this point, i gently removed the stylet wire that was still protruding and realized that a 2.5cm piece of the stylet wire had detached from the stylet.The remaining portion of the stylet was not bent or kinked.The picc was not bent or kinked.".

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11028712
• MDR Text Key: 222761973
• Report Number: 3006260740-2020-20991
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178
• Combination Product (y/n): N
• PMA/PMN Number: K053501
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1385108D5
• Device Lot Number: REEW1837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 108