MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Physical Resistance (2578); Material Integrity Problem (2978)

Patient Problem No Information (3190)

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reas1161 showed two other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported that during insertion the guide wire met resistance and upon removal it was noted it had a change in the shape of the tip.

Manufacturer Narrative

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 and was determined to be use related.One nitinol guidewire was returned for evaluation.An initial visual observation showed the majority of the coiled wire of the guidewire was severely unraveled and the core wire was observed to be broken.Blood residue was observed throughout the returned sample, with large amounts near the distal end of the unraveled section.A microscopic observation revealed kinks in the portion of the coiled wire that was not unraveled near the distal end.The most proximal end of the coiled wire was observed to be detached from the core wire.The fracture site of the core wire was observed to be tapered and the fracture surface was observed to be mostly flat and granular in texture, indicating tensile failure.The damage observed in the returned guidewire appears to have been caused by withdrawal of the guidewire over the bevel of an introducer needle and/or excessive withdrawal force against resistance.The product ifu cautions: "if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire." a lot history review (lhr) of reas1161 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that during insertion the guide wire met resistance and upon removal it was noted it had a change in the shape of the tip.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7195520
• MDR Text Key: 97584676
• Report Number: 3006260740-2018-00012
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 3275118
• Device Lot Number: REAS1161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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