MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redr3308 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The rn reported the following, "attempting to place a picc, unsuccessful to thread line passing subclavian area, picc line retrieved after several attempts made with no avail.Once line was retrieved we noticed a small piece of the wire was out the tip of catheter and while examining it realized there was a small segment of the wire that was cut off the mail wire (the magnetic side)." on 1/16/2020- additional information received stated there was no portion of the wire left in the patient.
Event or Problem Description
The rn reported the following, "attempting to place a picc, unsuccessful to thread line passing subclavian area, picc line retrieved after several attempts made with no avail.Once line was retrieved we noticed a small piece of the wire was out the tip of catheter and while examining it realized there was a small segment of the wire that was cut off the mail wire (the magnetic side)." (b)(6)2020 - additional information received stated there was no portion of the wire left in the patient.
Additional 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 3cg stylet was confirmed.One 5fr triple-lumen (t/l) powerpicc was returned for investigation.The catheter had been trimmed to length at the 46cm depth mark.The 3cg stylet had been removed from the catheter and was received separate from the t-lock extension set.A complete break was observed in the polyimide tubing.The distal segment of the polyimide tubing was 4.0cm in length.The polyimide tubing was kinked in multiple locations.The core wire broke 1cm distal to the break in the polyimide tubing.A microscopic examination revealed that the kinks in the polyimide tubing were located between magnets.The adjoining surfaces of the broken polyimide tubing appeared uneven and granular.The wall thickness of the polyimide tubing was within specification.It was reported that the insertion process was unsuccessful.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.¿ a lot history review (lhr) of redr3308 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9649460
• Report Number: 3006260740-2020-00319
• Device Sequence Number: 19532990
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: REDR3308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 87