MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT FOR INSERTION OF GROSHON; CATHETER INTRODUCER

Catalog Number	0607780
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.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, but the cause of the damage is unknown.One guidewire from an introducer kit was returned for investigation.It was reported that the guidewire was too soft to use.The guidewire was received with multiple kinks, which were located 2.7cm, 4.0cm, 6.0cm, 12.0cm, 15.0cm, 22.5cm, and 25.5cm from the apex of the curve at the j-tip.A tactual investigation revealed that the coil wire was intact at the j-tip, but there was a break in the weld tip at the proximal end of the guidewire, which allowed the coil wire to stretch over the core wires.The damage at the proximal weld tip may have contributed the alleged softness at the j-tip since the coil wire was unrestrained.The guidewire was most likely damaged during use, but the exact cause is unknown.The other components from the introducer kit, which may have provided evidence related to the guidewire damage, were not returned for investigation.The product ifu provides the following cautions regarding use of the guidewire.¿do not insert guidewire beyond the bevel of the needle while removing straightener from the needle hub in order to prevent guidewire damage or shearing.If the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of rezh0975 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The tip of the guide wire was reportedly too soft to use.Another one was used to complete procedure.

• Brand Name: GROSHONG 8F PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT FOR INSERTION OF GROSHON
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5563086
• Report Number: 3006260740-2016-00154
• Device Sequence Number: 13671942
• Product Code: DYB
• UDI-Device Identifier: 00801741038358
• UDI-Public: (01)00801741038358(17)200731(10)REZH0975
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2016

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 0607780
• Device Lot Number: REZH0975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1