MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "the power picc solo [left] behind a ¿piece¿ in the patient.I believe perhaps a piece of the stylet?.They did retrieve and save the ¿piece'.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv2191 showed no other similar product complaint(s) from this lot number.
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 stylet is confirmed; however, the exact cause is unknown.One 3cg stylet segment was returned for evaluation.An initial visual observation showed use residue on the returned sample.The stylet segment was observed to be of the distal tip of the stylet and was found to contain the epoxy tip.The stylet segment was found to be approximately 3.7 cm long.A slight bend was observed in the stylet approximately 0.3 cm distal to the break site.A microscopic observation revealed the break site in the polyimide tubing was uneven with a rough surface texture and plastic deformation.Some tapering, tearing, and slight delamination were observed in the polyimide tubing at the break site.The observed bend in the stylet segment was found to be between the first magnet interface distal to the break site.While the exact cause of the break in the returned stylet is unknown, possible causes 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 "the power picc solo [left] behind a ¿piece¿ in the patient.I believe perhaps a piece of the stylet?.They did retrieve and save the ¿piece'.".

• Brand Name: POWERPICC SOLO HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13180584
• Report Number: 3006260740-2021-05526
• Device Sequence Number: 14880774
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 1395108QD
• Device Lot Number: REFV2191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown