MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rees3287 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "we had a magnet break off a line while we were inserting it.Chest xray verified that it was present in the patient¿s lung." "what they¿re being treated for: tpn." "other relevant history: patient with history of multiple infections requiring iv antibiotics and picc line placement." "does the patient have an infectious disease?: hx of mrsa and vre.".
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken tls stylet is confirmed; however, the exact cause is unknown.One tls stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the stylet appeared to be missing and bends were observed in the stylet proximal to the break site.A microscopic observation revealed the polyimide tubing at the break site was plastically deformed and folded over the distal end of a magnet.While the exact cause of the break in the returned stylet could not be determined from the evidence observed on the returned sample, possible causes of the break include excessive manipulation of the stylet prior to or during placement and advancement/retraction of the stylet against resistance.
Event or Problem Description
It was reported "we had a magnet break off a line while we were inserting it.Chest xray verified that it was present in the patient¿s lung." "what they¿re being treated for: tpn" "other relevant history: patient with history of multiple infections requiring iv antibiotics and picc line placement" "does the patient have an infectious disease?: hx of mrsa and vre".

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM
• 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: 10707824
• Report Number: 3006260740-2020-20189
• Device Sequence Number: 19570609
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9395108QD
• Device Lot Number: REES3287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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: Required Intervention
• Patient Age: 43 YR