MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number IPN035616

Device Problems Difficult to Insert (1316); Kinked (1339); Retraction Problem (1536); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

The patient presented to ed with urinary retention.Patient with severe stricture at the penis aspect.Multiple attempts to place a foley catheter including coude.Attempts were made with #12, #14 #16, #18 and none fit through the glans of penis, unable to pass the foley catheter.The seldinger technique for a suprapubic catheter placement was utilized with the central line kit.Ultrasound guide and probe was used.The central line needle was introduced into the bladder and observed to enter the bladder.Urine started coming out of the bladder.Partial decompression was noticed.The physician introduced the wire into the bladder then removed the needle from the bladder and applied the dilator.An attempt to place the triple lumen of the central catheter line kit was made when the physician noticed he was unable to retract the wire through the triple lumen.Several attempts were made to retract the wire and no success.Ct abdomen and pelvis was completed and resulted in metallic wire in the lower abdomen/pelvis anterior and along the inferior aspect of the urinary bladder.The wire appears kinked at the midline just deep to the abdominal musculature.The patient was transferred to another surgery for urology consult and removal.Procedure: urethral dilation and placement of foley catheter with removal of guide wire was completed.No patient harm.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7348380
• MDR Text Key: 102738439
• Report Number: 7348380
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: IPN035616
• Device Catalogue Number: CDC-45703
• Device Lot Number: 1097858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR