MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 5F; CHRONIC CATHETERS

Model Number	0720515
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2024).
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the guidewire of the device allegedly broke.It was further reported that 1 cm of the device could not be retrieved using endovascular technique.The current status of the patient is unknown.
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that ¿picc guide wire broke off (small distal tip) with attempt insertion of picc rue; ir placement.Difficult picc placement, most likely vasospasm.No harm to patient, 1 cm could not be retrieved using endovascular technique.".
Event or Problem Description
It was reported that during a procedure, the guidewire of the device allegedly broke off and had material separation.It was further reported that the device separated.Guidewire segments were left inside the patient and segments allegedly could not be retrieved using endovascular technique, which required additional medical intervention.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one guidewire was returned for evaluation.Gross visual, microscopic visual and dimensional evaluations were performed.The investigation is unconfirmed for the reported fracture and material separation issues, as no breaks were observed throughout the distal end.The investigation is unconfirmed for the identified stretched issue, as the distal end of the guidewire appeared to be uncoiling exposing the inner guidewire.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The dimensions are slightly out of tolerance in the affected portion that may be due to unravelling noted at multiple places in the wire.The dimensions are not out of tolerance for the unaffected portion of the wire.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: (expiry date: 08/2024).H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 5F
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13755573
• Report Number: 3006260740-2022-00784
• Device Sequence Number: 4466145
• Product Code: LJS
• UDI-Device Identifier: 00801741036613
• UDI-Public: (01)00801741036613
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2022

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: 0720515
• Device Catalogue Number: 0720515
• Device Lot Number: REFR2262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 05/16/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 03/17/2022; 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Female