MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 7F PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT BASIC KIT; CATHETER INTRODUCER

Catalog Number	0601170
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rezh1523 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 03/16/2016 - bas engineers found additional guidewire returned for evaluation.The guidewire is intact at both ends and blood residue is evident.The guidewire is kinked in two places.It is stretched and a segment of the wrapping is missing.On 03/18/2016 - based on the original event, the patient had pain and there are risks of injury to the vein and of loss of part of the guidewire in the patient.
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed, and appears to be use related.The implicated and returned product was a needle and guidewire from a 7 fr ptfe introducer kit.The needle had blood residue on the distal end of the needle.The outer wire had slid off the central core wire, exposing approximately 8.5 cm of central core wire.A kink was observed 39.7 cm from the proximal end of the guidewire.Functional testing was performed by threading the guidewire through the proximal end of the needle.The guidewire caught at the kink previously observed, however was able to be fully threaded through the guidewire.Microscopic examination of the needle showed a metallic gleam on the top of the needle bevel.The location and surface characteristics of the damage is consistent with wear from a guidewire.The location of the damage on the guidewire indicates the guidewire was threaded through proximal end first, and then was retracted against the needle, shearing the outer portion of the guidewire, causing it to fray.The instructions for use caution: ¿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.¿.

• Brand Name: 7F PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT BASIC KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5552871
• Report Number: 3006260740-2016-00150
• Device Sequence Number: 356810
• Product Code: DYB
• UDI-Device Identifier: 00801741038327
• UDI-Public: (01)00801741038327(17)200828(10)REZH1523
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2016

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: 08/28/2020
• Device Catalogue Number: 0601170
• Device Lot Number: REZH1523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1