MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL POLYURETHANE CATHETER RADIOLOGY (70 CM GUIDEWIRE); 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	02/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refs0039 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was no progression of the guide wire after introduction approximately 15 cm, in withdrawal, guide wire presents resistance after approximately 5 cm, it was reintroduced and pulled twice, with movement of the limb angle, in the third attempt the wire slides easily, however the notifier observes and "feels" the opening of the filament and new resistance, pause removed and observe the opening of the wire (peeled approximately 1.5 cm).Additional information received: was there any harm to the patient/health worker? uninformed was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? it was necessary to intervene by a vascular physician to remove the guide wire.And non-contrast ct and rx were performed to exclude foreign body has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) no blood was reported and the patient had not used chemotherapy until that moment.
Event or Problem Description
It was reported that there was no progression of the guide wire after introduction approximately 15 cm, in withdrawal, guide wire presents resistance after approximately 5 cm, it was reintroduced and pulled twice, with movement of the limb angle, in the third attempt the wire slides easily, however the notifier observes and "feels" the opening of the filament and new resistance, pause removed and observe the opening of the wire (peeled approximately 1.5 cm).Additional information received: ¿ was there any harm to the patient/health worker? uninformed ¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? it was necessary to intervene by a vascular physician to remove the guide wire.And non-contrast ct and rx were performed to exclude foreign body ¿ has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) no blood was reported and the patient had not used chemotherapy until that moment.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs which depicted a guidewire.The wire was in its plastic hoop in its plastic tray.The tip of the wire extended from the hoop.The tip exhibited curved shape memory.The tip of the guidewire appeared broken and elongated.Guidewire damage was evident in the submitted photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include guidewire retraction against the needle bevel and attempted insertion against resistance.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that there was no progression of the guide wire after introduction approximately 15 cm, in withdrawal, guide wire presents resistance after approximately 5 cm, it was reintroduced and pulled twice, with movement of the limb angle, in the third attempt the wire slides easily, however the notifier observes and "feels" the opening of the filament and new resistance, pause removed and observe the opening of the wire (peeled approximately 1.5 cm).Additional information received: ¿ was there any harm to the patient/health worker? uninformed.¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? it was necessary to intervene by a vascular physician to remove the guide wire.And non-contrast ct and rx were performed to exclude foreign body.¿ has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) no blood was reported and the patient had not used chemotherapy until that moment.
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 damaged guidewire was confirmed.The products returned for evaluation were one 0.018 in.Guidewire in a plastic hoop, one 4 fr single lumen powerpicc catheter, and one 21 g introducer needle.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product samples were evaluated, and the guidewire was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: ¿ shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle).¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire.¿ damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: POWERPICC 4F SL POLYURETHANE CATHETER RADIOLOGY (70 CM GUIDEWIRE)
• 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: 13737647
• Report Number: 3006260740-2022-00763
• Device Sequence Number: 5069511
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3174155
• Device Lot Number: REFS0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 07/29/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 03/31/2022; 08/03/2022
• 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