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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regt2196 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that they "had an incident with a picc line on friday.The picc line somehow became knotted inside the patient¿s vein and had to be removed in cath lab." additional information received: a detailed description of the event: picc line being placed for vasopressor therapy.Picc didn't appear to be ¿dropping¿ right, appeared to be flipping and curling.Pulled wire back to reset sherlock.Tried to advance wire but couldn't get the wire in completely, felt resistance.Unable to draw blood or flush as well.Attempted to pull the picc line back but felt resistance when trying to line out.Got an xray to view what was happening with the line and saw that the line was knotted inside vessel.Physician took patient to cath lab to remove line.
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 complaint of a catheter knot was confirmed.One 5 fr tl powerpicc solo catheter was returned for evaluation.The catheter was present passing through the 5 fr microez microintroducer which had not been spit.A tightly wound knot was noted approximately 4 cm from the distal end of the catheter.The catheter was measured distal to the knot in order to measure the catheter dimensional characteristics.The wall thicknesses and lumen distance were found to be within manufacturing specification.Based on the information provided, likely contributing factors include repeated advancement against resistance and kinking of the catheter.The reported event description indicates placement difficulty was experienced which may have been a contributing factor.Since the catheter was observed to have become knotted, the complaint is confirmed.
Event or Problem Description
It was reported by the customer that they "had an incident with a picc line on friday.The picc line somehow became knotted inside the patient¿s vein and had to be removed in cath lab." additional information received: a detailed description of the event: picc line being placed for vasopressor therapy.Picc didn¿t appear to be ¿dropping¿ right, appeared to be flipping and curling.Pulled wire back to reset sherlock.Tried to advance wire but couldn¿t get the wire in completely, felt resistance.Unable to draw blood or flush as well.Attempted to pull the picc line back but felt resistance when trying to line out.Got an xray to view what was happening with the line and saw that the line was knotted inside vessel.Physician took patient to cath lab to remove line.

• Brand Name: POWERPICC SOLO HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16510658
• Report Number: 3006260740-2023-00739
• Device Sequence Number: 20226036
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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 Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 1395108QD
• Device Lot Number: REGT2196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG