MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD GUIDEWIRE PEG SYSTEM WITH SOFT SILICONE RETENTION DOME 20F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000331
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that when the package was opened and the hcp (health care professional) went to take the guidewire out of the hoop it was stuck, the guidewire was pulled and finally came out.It was alleged that the guidewire was frayed.Reportedly, another kit was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one guidewire in guidewire hoop was returned for evaluation.The sample appeared to be clean.The wire was bent and stretched throughout.Therefore, the investigation is confirmed for the reported frayed guidewire.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.As the reported event details state the guidewire was difficult to remove from the hoop, possible contributing factors include occlusion of the hoop, attempting to remove guidewire from hoop before removing retaining plug and rapid/forceful removal of guidewire from hoop.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 10/2019).
Event or Problem Description
It was reported that when the package was opened and the hcp (health care professional) went to take the guidewire out of the hoop it was stuck, the guidewire was pulled and finally came out.It was alleged that the guidewire was frayed.Reportedly, another kit was used to complete the procedure.There was no reported patient injury.

• Brand Name: BARD GUIDEWIRE PEG SYSTEM WITH SOFT SILICONE RETENTION DOME 20F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8104960
• Report Number: 3006260740-2018-03407
• Device Sequence Number: 1960921
• Product Code: KNT
• UDI-Device Identifier: 00801741080920
• UDI-Public: (01)00801741080920
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 000331
• Device Catalogue Number: 000331
• Device Lot Number: HUBX0615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1