MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 6 FR 90CM; CATHETER, FLOW DIRECTED

Model Number IPN000084

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the md was performing the procedure according to the ifu.The md found that the balloon would not inflate due to a catheter defect.As a result, the md judged it as a defective product and another catheter was used at the same insertion site.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the md was performing the procedure according to the ifu.The md found that the balloon would not inflate due to a catheter defect.As a result, the md judged it as a defective product and another catheter was used at the same insertion site.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not inflate in use is not confirmed.No damage or abnormalities were noted to the returned sample upon receipt.The balloon inflated as per specifications during the investigation, and the returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: BERMAN 6 FR 90CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12120588
• MDR Text Key: 260016036
• Report Number: 3010532612-2021-00184
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002280
• UDI-Public: 00801902002280
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: IPN000084
• Device Catalogue Number: AI-07136
• Device Lot Number: 16F19M0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1