MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Catalog Number 0668945

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  malfunction  

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, frequency 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 is confirmed; however, the exact cause is unknown.One 0.018 in.Guidewire was returned for evaluation.An initial visual observation showed the guidewire was bent in three locations and the proximal end was observed to be slightly curved.The core wire of the guidewire appeared to be intact during tactile evaluation.A microscopic observation revealed the coiled wire at the proximal tip of the guidewire was deformed and some coils were displaced.The distal end of the guidewire was observed to be undamaged.The undamaged distal end of the unraveled guidewire was twisted firmly and repeatedly in an attempt to recreate the failure, and after this repeated twisting, the coiled wire at the distal end was observed to become deformed in a similar way as the proximal end of the guidewire.It is possible this damage occurred during manufacturing, packaging, handling, or use; however it is not possible to determine when or where it took place.A lot history review (lhr) of rebx0604 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the tip of the guidewire where connected the introducer sheath was uneven and the sheath cannot be delivered.On 05/31/2018 - returned guidewire has bent, curled, and expanded coils.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7614849
• MDR Text Key: 112002127
• Report Number: 3006260740-2018-01439
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Device Lot Number: REBX0604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1