MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER W/BIOPATCH; 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	08/31/2021
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 refs2677 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s "customer called to request educational materials for a powerpicc.She reported that they had the tip of the stylet break off in a patient and lodge in the right ventricle on 8/20.She reported this to med watch.The foreign body was discovered two weeks after when the patient came back to the hospital for a different reason, but a ct was performed and the stylet tip was discovered at that point.She reported that patient did not suffer any adverse effects, other then having to have a procedure to remove the tip." ms&s response: "i provided the provena ifu and forwarded the case to product complaints." additional information received 09/28/2021 "date of insertion: 08/20/2021.The picc insertion nurse reports the picc line insertion was uneventful.She inserted the picc in the left arm due to patient having osteomyelitis, gangrene of right thumb and noted swelling up the right forearm.The picc line was not trimmed at all due to extra length needed for left sided picc.Procedure took approximately 25 to 30 minutes and proper placement was confirmed by radiologist.The radiologist did not see the foreign body on initial confirm placement x-ray.He was looking for proper placement of the catheter.It is not a standard of practice to inspect the tip of stylet removed from the picc so she had no reason to suspect the tip of guidewire to be missing.Foreign body noted in right ventricle on ct scan on 08/31/2021 foreign body removed by cardiologist on (b)(6) 2021.Approximately 2.5 cm from tip of guidewire we do have the piece of guidewire that was removed from the patient.My dcqi requested someone from bard is welcome to come here to examine it if needed.We will not be mailing it out.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a fractured stylet is confirmed but the exact cause remains unknown.Two photo samples of a 3cg stylet segment were provided for evaluation.The first image shows a fractured segment of the distal 3cg stylet tip.The stylet segment is besides a ruler and measures to be approximately 3 cm.A kink in the segment is present proximately 2.4 cm from the distal end.The second photo appears to show the fractured segment with the kink present.Blood residue is visible on the device.Based on the photos provided, possible contributing factors include advancement or retraction against resistance and kinking of the stylet during insertion.Since the stylet was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.
Event or Problem Description
It was reported via ms&s "customer called to request educational materials for a powerpicc.She reported that they had the tip of the stylet break off in a patient and lodge in the right ventricle on (b)(6).She reported this to med watch.The foreign body was discovered two weeks after when the patient came back to the hospital for a different reason, but a ct was performed and the stylet tip was discovered at that point.She reported that patient did not suffer any adverse effects, other then having to have a procedure to remove the tip." ms&s response: "i provided the provena ifu and forwarded the case to product complaints." additional information received 09/28/2021 "date of insertion: (b)(6) 2021.The picc insertion nurse reports the picc line insertion was uneventful.She inserted the picc in the left arm due to patient having osteomyelitis, gangrene of right thumb and noted swelling up the right forearm.The picc line was not trimmed at all due to extra length needed for left sided picc.Procedure took approximately 25 to 30 minutes and proper placement was confirmed by radiologist.The radiologist did not see the foreign body on initial confirm placement x-ray.He was looking for proper placement of the catheter.It is not a standard of practice to inspect the tip of stylet removed from the picc so she had no reason to suspect the tip of guidewire to be missing.Foreign body noted in right ventricle on ct scan on (b)(6) 2021 foreign body removed by cardiologist on (b)(6) 2021.Approximately 2.5 cm from tip of guidewire we do have the piece of guidewire that was removed from the patient.My dcqi requested someone from bard is welcome to come here to examine it if needed.We will not be mailing it out." (b)(6) 2021: medwatch received stated, "picc insertion on (b)(6) 2021 x-ray of picc line placement performed and no foreign body notes patient was discharged home with on (b)(6) 2021 returned to emergency room with intractable nausea and vomiting.She also had reported some sob and chest pain for past several days prior ct scan ordered of chest and abdomen.A foreign body noted in heart on ct scan.A chest x-ray was obtained and confirmed foreign body in right ventricle of heart.Heart cauterizations performed to remove the foreign body.Cardiologist was able to removed the foreign body which is believed to ne a piece of the picc insertion guidewire.The foreign body approximately 1 to 1 1/2 inches in length foreign body was placed in a container and transported to laboratory for further inspection.".

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER W/BIOPATCH
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12628154
• Report Number: 3006260740-2021-04354
• Device Sequence Number: 19675391
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: (01)00801741155215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: S1295108FD5
• Device Lot Number: REFS2677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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