MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp1346 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that powermidline 4 fr single attempted to be placed.Abstained access with needle and attempted to thread the guidewire.Met resistance and then attempted to pull the guidewire out of needle and met resistance and then tried to pull the needle and guidewire out at the same time and met resistance as well.Then they cut the wire above the needle to get the needle off.After the needle was off, the coiled tip of the guidewire had come uncoiled to the length of 36 cm.Nurse nicked the patient and dr.Completely pulled out the remainder of the intact guidewire that was in patient.This all resulted in no patient harm.

Event Description

It was reported that powermidline 4 fr single attempted to be placed.Abstained access with needle and attempted to thread the guidewire.Met resistance and then attempted to pull the guidewire out of needle and met resistance and then tried to pull the needle and guidewire out at the same time and met resistance as well.Then they cut the wire above the needle to get the needle off.After the needle was off, the coiled tip of the guidewire had come uncoiled to the length of 36 cm.Nurse nicked the patient and dr.Completely pulled out the remainder of the intact guidewire that was in patient.This all resulted in no patient harm.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.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 0.018 in.Nitinol guidewire was returned for evaluation.An initial visual observation showed the core wire of the guidewire was broken and the coiled wire was severely unraveled.Use residue was observed throughout the sample.A microscopic observation revealed the weld tip was present and intact.The distal break site of the core wire was observed to be tapered with an uneven and granular surface texture, which is evidence of a tensile break cause by excessive pulling force.The product ifu states: ¿do not use excessive force when introducing guidewire¿ and ¿if the guidewire must be withdrawn while the needle is inserted, remove both needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ an examination of the wire structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8757589
• MDR Text Key: 149926487
• Report Number: 3006260740-2019-01862
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REDP1346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention