MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SP 4F DL MAX; 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	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeq3650 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported the wire broke inside the patient.The rn stated, "i believe it was the stylet, but not sure yet.It is from a picc placed a month ago, and the piece is now lodged in the pulmonary artery." add info rcvd 10/27/2020: difficulty advancing picc past shoulder.What type of catheter securement was utilized: statlock.Was there patient harm reported?: so far pt is asymptomatic.Waiting to see if wire can be removed in ir.
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, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a wire break was confirmed but the cause could not be determined from evaluation of the provided x-ray imagery.Five x-ray images were provided for evaluation.Four of those images contained a bright white linear object which was circled with highlighter by the complainant.The object appeared to be near the upper arm/shoulder area of the patient and was in-line with a catheter-like object but it could not be determined if that white linear object was within, or exterior to, the catheter.The length scale was included on only one of the images but the image of the bright white linear object had been cut off which prohibited an approximation of the length of the object.The object appeared similar to how a metallic, or very dense, object would appear via x-ray, and was the approximate diameter of either a guidewire or 3cg stylet, but positive identification could not be determined from the images.Likewise the root cause for the alleged event could not be determined through evaluation of the provided images.
Event or Problem Description
It was reported the wire broke inside the patient.The rn stated, "i believe it was the stylet, but not sure yet.It is from a picc placed a month ago, and the piece is now lodged in the pulmonary artery." add info rcvd 10/27/2020: difficulty advancing picc past shoulder what type of catheter securement was utilized: statlock was there patient harm reported?: so far pt is asymptomatic.Waiting to see if wire can be removed in ir.

• Brand Name: DOT PROV SP 4F DL MAX
• 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: 10864654
• Report Number: 3006260740-2020-20572
• Device Sequence Number: 14226793
• Product Code: LJS
• UDI-Device Identifier: 00801741134166
• UDI-Public: (01)00801741134166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 12/30/2020

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: S1274108PD
• Device Lot Number: REEQ3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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: 9 YR
• Patient Weight: 35