MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC TPS STYLET (4F) (SL); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000670
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "during an ecg picc procedure i noticed that the transducer wire signal was lost suddenly.Upon removal i discovered the tip broken in two spots.The distal tip was broken off by hand easily but i thought id save the rest to send back to you" additional information received (b)(6) 2021: transducer tip broke suddenly during initial insertion in two spots.When transducer feed went out transducer wire was removed and examined.Tip intact but severely broken.Tip easily removed by hand and thrown out.Second piece not removed.Was there patient harm reported?: no.Had to redo procedure due to inability to navigate picc with broken transducer.
Event or Problem Description
It was reported "during an ecg picc procedure i noticed that the transducer wire signal was lost suddenly.Upon removal i discovered the tip broken in two spots.The distal tip was broken off by hand easily but i thought id save the rest to send back to you" additional information received 02/18/2021: transducer tip broke suddenly during initial insertion in two spots.When transducer feed went out transducer wire was removed and examined.Tip intact but severely broken.Tip easily removed by hand and thrown out.Second piece not removed.Was there patient harm reported?: no.Had to redo procedure due to inability to navigate picc with broken transducer.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the stylet was observed to be missing and a bend was observed in the stylet approximately 0.5 cm proximal to the break site.A microscopic observation revealed the break site was mostly straight but uneven, and the edges of the polyimide tubing were observed to be plastically deformed.Kinks/bends were observed in the polyimide tubing between most of the magnets leading up to the break site.The observed fracture features were indicative of catheter and/or stylet kinking which likely occurred during the insertion process; however, the exact circumstances providing for that type of event were ultimately unknown.Evaluation findings are in section h.11.

• Brand Name: POWERPICC TPS STYLET (4F) (SL)
• Common Device Name: 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: 11474902
• Report Number: 3006260740-2021-00806
• Device Sequence Number: 3413386
• Product Code: LJS
• UDI-Device Identifier: 00801741130861
• UDI-Public: (01)00801741130861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: CK000670
• Device Catalogue Number: CK000670
• Device Lot Number: REEX2143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 68